A Study to Evaluate the Safety, Pharmacokinetics, and Pharmacodynamic Effects of MEDI5884 in Adults With Stable Coronary Heart Disease

Study identifier:D7870C00002

ClinicalTrials.gov identifier:NCT03351738

EudraCT identifier:N/A

CTIS identifier:N/A

Study Complete

Official Title

A Phase 2a Randomized, Double-blind, Placebo-controlled, Parallel-designed Study to Evaluate the Safety, Pharmacokinetics, and Pharmacodynamic Effects of MEDI5884 in Subjects with Stable Coronary Heart Disease

Medical condition

Stable Coronary Heart Disease

Phase

Phase 2

Healthy volunteers

Study drug

MEDI5884, Placebo

Sex

All

Actual Enrollment

133

Study type

Interventional

Age

45 Years - 80 Years

Date

Study Start Date: 13 Dec 2017

Primary Completion Date: 09 Nov 2018

Study Completion Date: 09 Nov 2018

Study design

Allocation: Randomized
Endpoint Classification: -
Intervention Model: Parallel Assignment
Masking: Double Blind
Primary Purpose: Treatment

Verification:

Verified 01 Mar 2020 by MedImmune, LLC

Collaborators

Inclusion and exclusion criteria

Location

Research Site

Jacksonville, FL, United States, 32216

Location

Research Site

Cincinnati, OH, United States, 45219

Location

Research Site

Fleming Island, FL, United States, 32003

Location

Research Site

Fargo, ND, United States, 58103

Location

Research Site

Marion, OH, United States, 43302

Location

Research Site

Indianapolis, IN, United States, 46260

Location

Research Site

Anniston, AL, United States, 36207

Location

Research Site

Port Orange, FL, United States, 32127

Arms	Assigned Interventions
Placebo Comparator: Placebo Participants will receive subcutaneous (SC) dose of placebo (volume matched to MEDI5884) on Days 1, 31, and 61.	Drug: Placebo Participants will receive SC dose of placebo (volume matched to MEDI5884) on Days 1, 31, and 61.
Experimental: MEDI5884 50 mg Participants will receive SC dose of MEDI5884 50 mg on Days 1, 31, and 61.	Drug: MEDI5884 Participants will receive SC dose of MEDI5884 50 mg or 100 mg or 200 mg or 350 mg or 500 mg on Days 1, 31, and 61.
Experimental: MEDI5884 100 mg Participants will receive SC dose of MEDI5884 100 mg on Days 1, 31, and 61.	Drug: MEDI5884 Participants will receive SC dose of MEDI5884 50 mg or 100 mg or 200 mg or 350 mg or 500 mg on Days 1, 31, and 61.
Experimental: MEDI5884 200 mg Participants will receive SC dose of MEDI5884 200 mg on Days 1, 31, and 61.	Drug: MEDI5884 Participants will receive SC dose of MEDI5884 50 mg or 100 mg or 200 mg or 350 mg or 500 mg on Days 1, 31, and 61.
Experimental: MEDI5884 350 mg Participants will receive SC dose of MEDI5884 350 mg on Days 1, 31, and 61.	Drug: MEDI5884 Participants will receive SC dose of MEDI5884 50 mg or 100 mg or 200 mg or 350 mg or 500 mg on Days 1, 31, and 61.
Experimental: MEDI5884 500 mg Participants will receive SC dose of MEDI5884 500 mg on Days 1, 31, and 61.	Drug: MEDI5884 Participants will receive SC dose of MEDI5884 50 mg or 100 mg or 200 mg or 350 mg or 500 mg on Days 1, 31, and 61.

Participant Flow

Recruitment Details

Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
The study was conducted in the US between 13Dec2017 and 09Nov2018.

Pre-Assignment Details

Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
A total of 248 participants consented to participate in the study, of which 115 were screen failures. A total of 133 participants were randomized to the study of which only 132 received treatment. One participant was ineligible, being randomized by error but not followed or treated.

Reporting Groups

	Description
Placebo	Participants received subcutaneous (SC) dose of placebo (volume matched to MEDI5884) on Days 1, 31, and 61.
MEDI5884 50 mg	Participants received SC dose of MEDI5884 50 mg on Days 1, 31, and 61.
MEDI5884 100 mg	Participants received SC dose of MEDI5884 100 mg on Days 1, 31, and 61.
MEDI5884 200 mg	Participants received SC dose of MEDI5884 200 mg on Days 1, 31, and 61.
MEDI5884 350 mg	Participants received SC dose of MEDI5884 350 mg on Days 1, 31, and 61.
MEDI5884 500 mg	Participants received SC dose of MEDI5884 500 mg on Days 1, 31, and 61.

Participant Flow: Overall Study

	Placebo	MEDI5884 50 mg	MEDI5884 100 mg	MEDI5884 200 mg	MEDI5884 350 mg	MEDI5884 500 mg
STARTED	23	20	24	22	21	22
COMPLETED	23	19	24	21	21	22
NOT COMPLETED	0	1	0	1	0	0
Withdrawal by Subject	0	1	0	1	0	0

Baseline Characteristics

Analysis Population Description -- Explanation of how the number of participants for analysis was determined.

As-treated population included all participants who received any dose of study drug and analyzed according to the treatment they actually received.

Reporting Groups

	Description
Placebo	Participants received subcutaneous (SC) dose of placebo (volume matched to MEDI5884) on Days 1, 31, and 61.
MEDI5884 50 mg	Participants received SC dose of MEDI5884 50 mg on Days 1, 31, and 61.
MEDI5884 100 mg	Participants received SC dose of MEDI5884 100 mg on Days 1, 31, and 61.
MEDI5884 200 mg	Participants received SC dose of MEDI5884 200 mg on Days 1, 31, and 61.
MEDI5884 350 mg	Participants received SC dose of MEDI5884 350 mg on Days 1, 31, and 61.
MEDI5884 500 mg	Participants received SC dose of MEDI5884 500 mg on Days 1, 31, and 61.

Baseline Measures

	Placebo	MEDI5884 50 mg	MEDI5884 100 mg	MEDI5884 200 mg	MEDI5884 350 mg	MEDI5884 500 mg	Total
Number of Participants [units: Participants]	23	20	24	22	21	22	132
Age Continuous [units: Years] Mean ± Standard Deviation	66.3 ± 8.4	63.8 ± 8.4	67.4 ± 5.7	64.7 ± 8.9	67.5 ± 7.8	67.6 ± 8.6	66.3 ± 8.0
Sex: Female, Male [units: Participants]
Female	4	3	1	4	1	4	17
Male	19	17	23	18	20	18	115
Race (NIH/OMB) [units: Participants]
American Indian or Alaska Native	0	0	0	0	0	0	0
Asian	0	1	0	0	0	1	2
Native Hawaiian or Other Pacific Islander	1	1	0	0	0	0	2
Black or African American	1	1	1	2	1	2	8
White	21	17	23	20	20	19	120
More than one race	0	0	0	0	0	0	0
Unknown or Not Reported	0	0	0	0	0	0	0
Ethnicity (NIH/OMB) [units: Participants]
Hispanic or Latino	2	1	2	0	1	1	7
Not Hispanic or Latino	21	19	22	22	20	21	125
Unknown or Not Reported	0	0	0	0	0	0	0

Outcome Measures

1. Primary Outcome Measure: Number of Participants With Treatment Emergent Adverse Events (TEAEs) and Treatment Emergent Serious Adverse Events (TESAEs) [ Time Frame: Day 1 (Baseline) through Day 241 ]

Measure Type	Primary
Measure Name	Number of Participants With Treatment Emergent Adverse Events (TEAEs) and Treatment Emergent Serious Adverse Events (TESAEs)
Measure Description	An adverse event (AE) is any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. A serious adverse event (SAE) is an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. The TEAEs are defined as events present at baseline that worsened in intensity after administration of study drug or events absent at baseline that emerged after administration of study drug.
Time Frame	Day 1 (Baseline) through Day 241
Safety Issue?	Yes

Population Description

Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
As-treated population: All participants who received any dose of study drug and analyzed according to actual treatment they received. Reported data are through Day 151 for all participants, and Day 241 for participants with elevated anti-drug antibodies (ADA), low-density lipoprotein cholesterol (LDL-C), triglycerides (TG) levels at Day 151 visit.

Reporting Groups

	Description
Placebo	Participants received subcutaneous (SC) dose of placebo (volume matched to MEDI5884) on Days 1, 31, and 61.
MEDI5884 50 mg	Participants received SC dose of MEDI5884 50 mg on Days 1, 31, and 61.
MEDI5884 100 mg	Participants received SC dose of MEDI5884 100 mg on Days 1, 31, and 61.
MEDI5884 200 mg	Participants received SC dose of MEDI5884 200 mg on Days 1, 31, and 61.
MEDI5884 350 mg	Participants received SC dose of MEDI5884 350 mg on Days 1, 31, and 61.
MEDI5884 500 mg	Participants received SC dose of MEDI5884 500 mg on Days 1, 31, and 61.

Measured Values

	Placebo	MEDI5884 50 mg	MEDI5884 100 mg	MEDI5884 200 mg	MEDI5884 350 mg	MEDI5884 500 mg
Number of Participants Analyzed [units:participants]	23	20	24	22	21	22
Number of Participants With Treatment Emergent Adverse Events (TEAEs) and Treatment Emergent Serious Adverse Events (TESAEs) [units: Participants]
TEAEs	17	10	11	12	13	13
TESAEs	2	2	1	0	4	0

No statistical analysis provided for Number of Participants With Treatment Emergent Adverse Events (TEAEs) and Treatment Emergent Serious Adverse Events (TESAEs)

2. Primary Outcome Measure: Number of Participants With Clinically Important Changes in Electrocardiograms (ECGs) From Baseline [ Time Frame: Day 1 (Baseline) through Day 241 ]

Measure Type	Primary
Measure Name	Number of Participants With Clinically Important Changes in Electrocardiograms (ECGs) From Baseline
Measure Description	Number of participants with clinically important changes in ECGs from baseline are reported. Clinically important changes in ECGs is defined as any clinical significant difference in heart rate, RR interval, PR interval, QRS, and QT intervals from the primary lead of the digital 12-lead ECG from baseline.
Time Frame	Day 1 (Baseline) through Day 241
Safety Issue?	Yes

Population Description

Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
As-treated population included all participants who received any dose of study drug and analyzed according to the treatment they actually received. Reported data are through Day 151 for all participants, and Day 241 for participants with elevated ADA, LDL-C, and TG levels at Day 151 visit.

Reporting Groups

	Description
Placebo	Participants received subcutaneous (SC) dose of placebo (volume matched to MEDI5884) on Days 1, 31, and 61.
MEDI5884 50 mg	Participants received SC dose of MEDI5884 50 mg on Days 1, 31, and 61.
MEDI5884 100 mg	Participants received SC dose of MEDI5884 100 mg on Days 1, 31, and 61.
MEDI5884 200 mg	Participants received SC dose of MEDI5884 200 mg on Days 1, 31, and 61.
MEDI5884 350 mg	Participants received SC dose of MEDI5884 350 mg on Days 1, 31, and 61.
MEDI5884 500 mg	Participants received SC dose of MEDI5884 500 mg on Days 1, 31, and 61.

Measured Values

	Placebo	MEDI5884 50 mg	MEDI5884 100 mg	MEDI5884 200 mg	MEDI5884 350 mg	MEDI5884 500 mg
Number of Participants Analyzed [units:participants]	23	20	24	22	21	22
Number of Participants With Clinically Important Changes in Electrocardiograms (ECGs) From Baseline [units: Participants]	0	0	0	0	0	0

No statistical analysis provided for Number of Participants With Clinically Important Changes in Electrocardiograms (ECGs) From Baseline

3. Primary Outcome Measure: Number of Participants With Clinically Important Changes in Vital Signs From Baseline [ Time Frame: Day 1 (Baseline) through Day 241 ]

Measure Type	Primary
Measure Name	Number of Participants With Clinically Important Changes in Vital Signs From Baseline
Measure Description	Number of participants with clinically important changes in vital signs from baseline are reported. Vital signs measurements were obtained after the participant had rested in the supine position for at least 10 minutes at the recording time. Clinically important changes in vital signs from baseline is defined as any clinical significant difference in the vital sign parameters (blood pressure, heart rate, body temperature, and respiratory rate) from baseline.
Time Frame	Day 1 (Baseline) through Day 241
Safety Issue?	Yes

Population Description

Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
As-treated population included all participants who received any dose of study drug and analyzed according to the treatment they actually received. Reported data are through Day 151 for all participants, and Day 241 for participants with elevated ADA, LDL-C, and TG levels at Day 151 visit.

Reporting Groups

	Description
Placebo	Participants received subcutaneous (SC) dose of placebo (volume matched to MEDI5884) on Days 1, 31, and 61.
MEDI5884 50 mg	Participants received SC dose of MEDI5884 50 mg on Days 1, 31, and 61.
MEDI5884 100 mg	Participants received SC dose of MEDI5884 100 mg on Days 1, 31, and 61.
MEDI5884 200 mg	Participants received SC dose of MEDI5884 200 mg on Days 1, 31, and 61.
MEDI5884 350 mg	Participants received SC dose of MEDI5884 350 mg on Days 1, 31, and 61.
MEDI5884 500 mg	Participants received SC dose of MEDI5884 500 mg on Days 1, 31, and 61.

Measured Values

	Placebo	MEDI5884 50 mg	MEDI5884 100 mg	MEDI5884 200 mg	MEDI5884 350 mg	MEDI5884 500 mg
Number of Participants Analyzed [units:participants]	23	20	24	22	21	22
Number of Participants With Clinically Important Changes in Vital Signs From Baseline [units: Participants]	0	0	0	0	0	0

No statistical analysis provided for Number of Participants With Clinically Important Changes in Vital Signs From Baseline

4. Primary Outcome Measure: Number of Participants With Clinically Important Changes in Laboratory Parameters From Baseline [ Time Frame: Day 1 (Baseline) through Day 241 ]

Measure Type	Primary
Measure Name	Number of Participants With Clinically Important Changes in Laboratory Parameters From Baseline
Measure Description	Number of participants with clinically important changes in laboratory parameters from baseline are reported. Clinically important changes in laboratory parameters is defined as any clinical significant difference in analysis of serum chemistry, hematology, and urine from baseline.
Time Frame	Day 1 (Baseline) through Day 241
Safety Issue?	Yes

Population Description

Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
As-treated population included all participants who received any dose of study drug and analyzed according to the treatment they actually received. Reported data are through Day 151 for all participants, and Day 241 for participants with elevated ADA, LDL-C, and TG levels at Day 151 visit.

Reporting Groups

	Description
Placebo	Participants received subcutaneous (SC) dose of placebo (volume matched to MEDI5884) on Days 1, 31, and 61.
MEDI5884 50 mg	Participants received SC dose of MEDI5884 50 mg on Days 1, 31, and 61.
MEDI5884 100 mg	Participants received SC dose of MEDI5884 100 mg on Days 1, 31, and 61.
MEDI5884 200 mg	Participants received SC dose of MEDI5884 200 mg on Days 1, 31, and 61.
MEDI5884 350 mg	Participants received SC dose of MEDI5884 350 mg on Days 1, 31, and 61.
MEDI5884 500 mg	Participants received SC dose of MEDI5884 500 mg on Days 1, 31, and 61.

Measured Values

	Placebo	MEDI5884 50 mg	MEDI5884 100 mg	MEDI5884 200 mg	MEDI5884 350 mg	MEDI5884 500 mg
Number of Participants Analyzed [units:participants]	23	20	24	22	21	22
Number of Participants With Clinically Important Changes in Laboratory Parameters From Baseline [units: Participants]	0	0	0	0	0	0

No statistical analysis provided for Number of Participants With Clinically Important Changes in Laboratory Parameters From Baseline

5. Primary Outcome Measure: Number of Participants With Clinically Important Changes in Physical Examinations From Baseline [ Time Frame: Day 1 (Baseline) through Day 241 ]

Measure Type	Primary
Measure Name	Number of Participants With Clinically Important Changes in Physical Examinations From Baseline
Measure Description	Number of participants with clinically important changes in physical examinations from baseline are reported. Clinically important changes in physical examinations is defined as any clinical significant difference in general appearance, head, ears, eyes, nose, throat, neck, skin, heart, lung, abdomen, musculoskeletal system, endocrine system, nervous system, height, and weight from baseline.
Time Frame	Day 1 (Baseline) through Day 241
Safety Issue?	Yes

Population Description

Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
As-treated population included all participants who received any dose of study drug and analyzed according to the treatment they actually received. Reported data are through Day 151 for all participants, and Day 241 for participants with elevated ADA, LDL-C, and TG levels at Day 151 visit.

Reporting Groups

	Description
Placebo	Participants received subcutaneous (SC) dose of placebo (volume matched to MEDI5884) on Days 1, 31, and 61.
MEDI5884 50 mg	Participants received SC dose of MEDI5884 50 mg on Days 1, 31, and 61.
MEDI5884 100 mg	Participants received SC dose of MEDI5884 100 mg on Days 1, 31, and 61.
MEDI5884 200 mg	Participants received SC dose of MEDI5884 200 mg on Days 1, 31, and 61.
MEDI5884 350 mg	Participants received SC dose of MEDI5884 350 mg on Days 1, 31, and 61.
MEDI5884 500 mg	Participants received SC dose of MEDI5884 500 mg on Days 1, 31, and 61.

Measured Values

	Placebo	MEDI5884 50 mg	MEDI5884 100 mg	MEDI5884 200 mg	MEDI5884 350 mg	MEDI5884 500 mg
Number of Participants Analyzed [units:participants]	23	20	24	22	21	22
Number of Participants With Clinically Important Changes in Physical Examinations From Baseline [units: Participants]	0	0	0	0	0	0

No statistical analysis provided for Number of Participants With Clinically Important Changes in Physical Examinations From Baseline

6. Secondary Outcome Measure: Change From Baseline in Apolipoprotein B [ Time Frame: Day 1 (Baseline), and Days 31, 61, and 91 ]

Measure Type	Secondary
Measure Name	Change From Baseline in Apolipoprotein B
Measure Description	Change from baseline in apolipoprotein B is reported.
Time Frame	Day 1 (Baseline), and Days 31, 61, and 91
Safety Issue?	No

Population Description

Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
As-treated population included all participants who received any dose of study drug and analyzed according to the treatment they actually received. Here, "number analyzed" signifies number of participants analyzed for the specified time point.

Reporting Groups

	Description
Placebo	Participants received subcutaneous (SC) dose of placebo (volume matched to MEDI5884) on Days 1, 31, and 61.
MEDI5884 50 mg	Participants received SC dose of MEDI5884 50 mg on Days 1, 31, and 61.
MEDI5884 100 mg	Participants received SC dose of MEDI5884 100 mg on Days 1, 31, and 61.
MEDI5884 200 mg	Participants received SC dose of MEDI5884 200 mg on Days 1, 31, and 61.
MEDI5884 350 mg	Participants received SC dose of MEDI5884 350 mg on Days 1, 31, and 61.
MEDI5884 500 mg	Participants received SC dose of MEDI5884 500 mg on Days 1, 31, and 61.

Measured Values

	Placebo	MEDI5884 50 mg	MEDI5884 100 mg	MEDI5884 200 mg	MEDI5884 350 mg	MEDI5884 500 mg
Number of Participants Analyzed [units:participants]	23	20	24	22	21	22
Change From Baseline in Apolipoprotein B [units: mg/dL] Mean (Standard Deviation)
Day 31	3.3 (8.5)	0.5 (12.2)	5.1 (10.6)	2.2 (9.4)	7.1 (10.6)	7.1 (14.3)
Day 61	1.2 (13.9)	-1.2 (14.1)	3.5 (10.8)	2.6 (15.3)	3.7 (11.7)	6.2 (9.6)
Day 91	-0.5 (10.7)	3.6 (29.3)	2.3 (10.7)	2.0 (8.3)	2.9 (9.4)	7.8 (13.4)

No statistical analysis provided for Change From Baseline in Apolipoprotein B

7. Secondary Outcome Measure: Percent Change from Baseline in High Density Lipoprotein Cholesterol (HDL-C) [ Time Frame: Day 1 (Baseline), and Days 31, 61, and 91 ]

Measure Type	Secondary
Measure Name	Percent Change from Baseline in High Density Lipoprotein Cholesterol (HDL-C)
Measure Description	Percent change from baseline in HDL-C is reported.
Time Frame	Day 1 (Baseline), and Days 31, 61, and 91
Safety Issue?	No

Population Description

Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
As-treated population included all participants who received any dose of study drug and analyzed according to the treatment they actually received. Here, "number analyzed" signifies number of participants analyzed for the specified time point.

Reporting Groups

	Description
Placebo	Participants received subcutaneous (SC) dose of placebo (volume matched to MEDI5884) on Days 1, 31, and 61.
MEDI5884 50 mg	Participants received SC dose of MEDI5884 50 mg on Days 1, 31, and 61.
MEDI5884 100 mg	Participants received SC dose of MEDI5884 100 mg on Days 1, 31, and 61.
MEDI5884 200 mg	Participants received SC dose of MEDI5884 200 mg on Days 1, 31, and 61.
MEDI5884 350 mg	Participants received SC dose of MEDI5884 350 mg on Days 1, 31, and 61.
MEDI5884 500 mg	Participants received SC dose of MEDI5884 500 mg on Days 1, 31, and 61.

Measured Values

	Placebo	MEDI5884 50 mg	MEDI5884 100 mg	MEDI5884 200 mg	MEDI5884 350 mg	MEDI5884 500 mg
Number of Participants Analyzed [units:participants]	23	20	24	22	21	22
Percent Change from Baseline in High Density Lipoprotein Cholesterol (HDL-C) [units: Percent change] Mean (Standard Deviation)
Day 31	-3.08 (10.28)	7.37 (13.52)	22.95 (25.04)	27.25 (19.37)	44.12 (24.74)	55.80 (25.97)
Day 61	-4.69 (9.45)	4.58 (12.45)	28.28 (32.19)	37.65 (22.76)	39.74 (22.74)	49.58 (21.46)
Day 91	-3.62 (13.41)	1.98 (14.69)	21.82 (30.66)	35.63 (35.27)	43.29 (31.09)	48.31 (25.63)

No statistical analysis provided for Percent Change from Baseline in High Density Lipoprotein Cholesterol (HDL-C)

8. Secondary Outcome Measure: Area Under the Concentration-time Curve for 30 Days (AUC30d) After the Last Dose of MEDI5884 [ Time Frame: Day 61 (pre-dose), and on Days 64, 68, 71, and 91 ]

Measure Type	Secondary
Measure Name	Area Under the Concentration-time Curve for 30 Days (AUC30d) After the Last Dose of MEDI5884
Measure Description	AUC30d after the last dose of MEDI5884 is reported.
Time Frame	Day 61 (pre-dose), and on Days 64, 68, 71, and 91
Safety Issue?	No

Population Description

Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
Pharmacokinetic (PK) evaluable population included all participants who received any dose of MEDI5884 with at least one detectable post treatment serum concentration measurement.

Reporting Groups

	Description
MEDI5884 50 mg	Participants received SC dose of MEDI5884 50 mg on Days 1, 31, and 61.
MEDI5884 100 mg	Participants received SC dose of MEDI5884 100 mg on Days 1, 31, and 61.
MEDI5884 200 mg	Participants received SC dose of MEDI5884 200 mg on Days 1, 31, and 61.
MEDI5884 350 mg	Participants received SC dose of MEDI5884 350 mg on Days 1, 31, and 61.
MEDI5884 500 mg	Participants received SC dose of MEDI5884 500 mg on Days 1, 31, and 61.

Measured Values

	MEDI5884 50 mg	MEDI5884 100 mg	MEDI5884 200 mg	MEDI5884 350 mg	MEDI5884 500 mg
Number of Participants Analyzed [units:participants]	18	22	20	20	20
Area Under the Concentration-time Curve for 30 Days (AUC30d) After the Last Dose of MEDI5884 [units: μg⋅day/mL] Mean (Standard Deviation)	14.6 (27.3)	51.8 (54.8)	191 (176)	584 (294)	1020 (643)

No statistical analysis provided for Area Under the Concentration-time Curve for 30 Days (AUC30d) After the Last Dose of MEDI5884

9. Secondary Outcome Measure: Maximum Observed Serum Concentration (Cmax) of MEDI5884 After the Last Dose [ Time Frame: Day 61 (pre-dose), and on Days 64, 68, 71, 91, 111, and 151 ]

Measure Type	Secondary
Measure Name	Maximum Observed Serum Concentration (Cmax) of MEDI5884 After the Last Dose
Measure Description	Maximum observed serum concentration (Cmax) of MEDI5884 after the last dose is reported.
Time Frame	Day 61 (pre-dose), and on Days 64, 68, 71, 91, 111, and 151
Safety Issue?	No

Population Description

Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
The PK evaluable population included all participants who received any dose of MEDI5884 with at least one detectable post treatment serum concentration measurement.

Reporting Groups

	Description
MEDI5884 50 mg	Participants received SC dose of MEDI5884 50 mg on Days 1, 31, and 61.
MEDI5884 100 mg	Participants received SC dose of MEDI5884 100 mg on Days 1, 31, and 61.
MEDI5884 200 mg	Participants received SC dose of MEDI5884 200 mg on Days 1, 31, and 61.
MEDI5884 350 mg	Participants received SC dose of MEDI5884 350 mg on Days 1, 31, and 61.
MEDI5884 500 mg	Participants received SC dose of MEDI5884 500 mg on Days 1, 31, and 61.

Measured Values

	MEDI5884 50 mg	MEDI5884 100 mg	MEDI5884 200 mg	MEDI5884 350 mg	MEDI5884 500 mg
Number of Participants Analyzed [units:participants]	18	22	20	20	20
Maximum Observed Serum Concentration (Cmax) of MEDI5884 After the Last Dose [units: μg/mL] Mean (Standard Deviation)	1.01 (1.34)	4.63 (2.95)	11.9 (7.77)	28.5 (13.0)	46.3 (24.6)

No statistical analysis provided for Maximum Observed Serum Concentration (Cmax) of MEDI5884 After the Last Dose

10. Secondary Outcome Measure: Terminal Elimination Half-life (t½) of MEDI5884 After the Last Dose [ Time Frame: Day 61 (pre-dose), and on Days 64, 68, 71, 91, 111, and 151 ]

Measure Type	Secondary
Measure Name	Terminal Elimination Half-life (t½) of MEDI5884 After the Last Dose
Measure Description	Terminal half-life is the time required for the plasma concentration to fall by 50% during the terminal phase. The t½ of MEDI5884 after the last dose is reported.
Time Frame	Day 61 (pre-dose), and on Days 64, 68, 71, 91, 111, and 151
Safety Issue?	No

Population Description

Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
The PK evaluable population included all participants who received any dose of MEDI5884 with at least one detectable post treatment serum concentration measurement.

Reporting Groups

	Description
MEDI5884 50 mg	Participants received SC dose of MEDI5884 50 mg on Days 1, 31, and 61.
MEDI5884 100 mg	Participants received SC dose of MEDI5884 100 mg on Days 1, 31, and 61.
MEDI5884 200 mg	Participants received SC dose of MEDI5884 200 mg on Days 1, 31, and 61.
MEDI5884 350 mg	Participants received SC dose of MEDI5884 350 mg on Days 1, 31, and 61.
MEDI5884 500 mg	Participants received SC dose of MEDI5884 500 mg on Days 1, 31, and 61.

Measured Values

	MEDI5884 50 mg	MEDI5884 100 mg	MEDI5884 200 mg	MEDI5884 350 mg	MEDI5884 500 mg
Number of Participants Analyzed [units:participants]	0	2	7	14	14
Terminal Elimination Half-life (t½) of MEDI5884 After the Last Dose [units: Days] Mean (Standard Deviation)		7.56 (6.4)	8.09 (2.80)	10.3 (3.53)	13.7 (5.86)

No statistical analysis provided for Terminal Elimination Half-life (t½) of MEDI5884 After the Last Dose

11. Secondary Outcome Measure: Number of Participants With Treatment-emergent Anti-drug Antibodies (ADA) to MEDI5884 [ Time Frame: Day 1 (pre-dose), on Day 8, Day 31 (pre-dose), Day 61 (pre-dose), on Days 151 and 241 ]

Measure Type	Secondary
Measure Name	Number of Participants With Treatment-emergent Anti-drug Antibodies (ADA) to MEDI5884
Measure Description	Treatment-emergent ADA is defined as the sum of treatment-induced ADA (post baseline-positive only) and treatment-boosted ADA (baseline ADA titer that was boosted to a 4-fold or higher level following drug administration).
Time Frame	Day 1 (pre-dose), on Day 8, Day 31 (pre-dose), Day 61 (pre-dose), on Days 151 and 241
Safety Issue?	No

Population Description

Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
As-treated population included all participants who received any dose of study drug and analyzed according to the treatment they actually received.

Reporting Groups

	Description
Placebo	Participants received subcutaneous (SC) dose of placebo (volume matched to MEDI5884) on Days 1, 31, and 61.
MEDI5884 50 mg	Participants received SC dose of MEDI5884 50 mg on Days 1, 31, and 61.
MEDI5884 100 mg	Participants received SC dose of MEDI5884 100 mg on Days 1, 31, and 61.
MEDI5884 200 mg	Participants received SC dose of MEDI5884 200 mg on Days 1, 31, and 61.
MEDI5884 350 mg	Participants received SC dose of MEDI5884 350 mg on Days 1, 31, and 61.
MEDI5884 500 mg	Participants received SC dose of MEDI5884 500 mg on Days 1, 31, and 61.

Measured Values

	Placebo	MEDI5884 50 mg	MEDI5884 100 mg	MEDI5884 200 mg	MEDI5884 350 mg	MEDI5884 500 mg
Number of Participants Analyzed [units:participants]	23	20	24	22	21	22
Number of Participants With Treatment-emergent Anti-drug Antibodies (ADA) to MEDI5884 [units: Participants]	1	1	1	3	3	3

No statistical analysis provided for Number of Participants With Treatment-emergent Anti-drug Antibodies (ADA) to MEDI5884

Serious Adverse Events

Time Frame	Day 1 through Day 241
Additional Description	No text entered.

Reporting Groups

	Description
Placebo	Participants received subcutaneous (SC) dose of placebo (volume matched to MEDI5884) on Days 1, 31, and 61.
MEDI5884 50 mg	Participants received SC dose of MEDI5884 50 mg on Days 1, 31, and 61.
MEDI5884 100 mg	Participants received SC dose of MEDI5884 100 mg on Days 1, 31, and 61.
MEDI5884 200 mg	Participants received SC dose of MEDI5884 200 mg on Days 1, 31, and 61.
MEDI5884 350 mg	Participants received SC dose of MEDI5884 350 mg on Days 1, 31, and 61.
MEDI5884 500 mg	Participants received SC dose of MEDI5884 500 mg on Days 1, 31, and 61.

Serious Adverse Events

Placebo

MEDI5884 50 mg

MEDI5884 100 mg

MEDI5884 200 mg

MEDI5884 350 mg

MEDI5884 500 mg

Total, serious adverse events

# participants affected / at risk

2/23 (8.70%)

2/20 (10.00%)

1/24 (4.17%)

0/22 (0.00%)

4/21 (19.05%)

0/22 (0.00%)

Cardiac disorders

Acute myocardial infarction¹,^†

# participants affected / at risk

0/23 (0.00%)

1/20 (5.00%)

0/24 (0.00%)

0/22 (0.00%)

0/21 (0.00%)

0/22 (0.00%)

# events

Cardiac disorders

Angina unstable¹,^†

# participants affected / at risk

0/23 (0.00%)

1/20 (5.00%)

1/24 (4.17%)

0/22 (0.00%)

2/21 (9.52%)

0/22 (0.00%)

# events

Cardiac disorders

Atrial fibrillation¹,^†

# participants affected / at risk

0/23 (0.00%)

0/20 (0.00%)

0/24 (0.00%)

0/22 (0.00%)

1/21 (4.76%)

0/22 (0.00%)

# events

Cardiac disorders

Myocardial infarction¹,^†

# participants affected / at risk

0/23 (0.00%)

0/20 (0.00%)

0/24 (0.00%)

0/22 (0.00%)

1/21 (4.76%)

0/22 (0.00%)

# events

General disorders and administration site conditions

Non-cardiac chest pain¹,^†

# participants affected / at risk

1/23 (4.35%)

0/20 (0.00%)

0/24 (0.00%)

0/22 (0.00%)

1/21 (4.76%)

0/22 (0.00%)

# events

Vascular disorders

Peripheral artery occlusion¹,^†

# participants affected / at risk

1/23 (4.35%)

0/20 (0.00%)

0/24 (0.00%)

0/22 (0.00%)

0/21 (0.00%)

0/22 (0.00%)

# events

†	Events were collected by systematic assessment
1	Term from vocabulary, MedDRA 21
2	Term from vocabulary, MedDRA 21.0

Other Adverse Events

Time Frame	Day 1 through Day 241
Additional Description	No text entered.

Frequency Threshold

Threshold above which other adverse events are reported	4.3%

Reporting Groups

	Description
Placebo	Participants received subcutaneous (SC) dose of placebo (volume matched to MEDI5884) on Days 1, 31, and 61.
MEDI5884 50 mg	Participants received SC dose of MEDI5884 50 mg on Days 1, 31, and 61.
MEDI5884 100 mg	Participants received SC dose of MEDI5884 100 mg on Days 1, 31, and 61.
MEDI5884 200 mg	Participants received SC dose of MEDI5884 200 mg on Days 1, 31, and 61.
MEDI5884 350 mg	Participants received SC dose of MEDI5884 350 mg on Days 1, 31, and 61.
MEDI5884 500 mg	Participants received SC dose of MEDI5884 500 mg on Days 1, 31, and 61.

Other Adverse Events

Placebo

MEDI5884 50 mg

MEDI5884 100 mg

MEDI5884 200 mg

MEDI5884 350 mg

MEDI5884 500 mg

Total, other (not including serious) adverse events

# participants affected / at risk

9/23 (39.13%)

9/20 (45.00%)

6/24 (25.00%)

12/22 (54.55%)

13/21 (61.90%)

13/22 (59.09%)

Cardiac disorders

Angina pectoris¹,^†

# participants affected / at risk

0/23 (0.00%)

0/20 (0.00%)

0/24 (0.00%)

0/22 (0.00%)

0/21 (0.00%)

1/22 (4.55%)

# events

Cardiac disorders

Angina unstable¹,^†

# participants affected / at risk

0/23 (0.00%)

1/20 (5.00%)

0/24 (0.00%)

0/22 (0.00%)

0/21 (0.00%)

0/22 (0.00%)

# events

Cardiac disorders

Atrial fibrillation¹,^†

# participants affected / at risk

0/23 (0.00%)

0/20 (0.00%)

0/24 (0.00%)

0/22 (0.00%)

1/21 (4.76%)

0/22 (0.00%)

# events

Cardiac disorders

Atrioventricular block second degree¹,^†

# participants affected / at risk

0/23 (0.00%)

1/20 (5.00%)

0/24 (0.00%)

0/22 (0.00%)

0/21 (0.00%)

0/22 (0.00%)

# events

Cardiac disorders

Palpitations¹,^†

# participants affected / at risk

0/23 (0.00%)

0/20 (0.00%)

1/24 (4.17%)

0/22 (0.00%)

1/21 (4.76%)

1/22 (4.55%)

# events

Eye disorders

Vitreous adhesions¹,^†

# participants affected / at risk

0/23 (0.00%)

0/20 (0.00%)

0/24 (0.00%)

1/22 (4.55%)

0/21 (0.00%)

0/22 (0.00%)

# events

Gastrointestinal disorders

Abdominal pain¹,^†

# participants affected / at risk

0/23 (0.00%)

1/20 (5.00%)

0/24 (0.00%)

0/22 (0.00%)

0/21 (0.00%)

0/22 (0.00%)

# events

Gastrointestinal disorders

Abdominal pain lower¹,^†

# participants affected / at risk

0/23 (0.00%)

0/20 (0.00%)

0/24 (0.00%)

1/22 (4.55%)

0/21 (0.00%)

0/22 (0.00%)

# events

Gastrointestinal disorders

Constipation¹,^†

# participants affected / at risk

0/23 (0.00%)

1/20 (5.00%)

0/24 (0.00%)

0/22 (0.00%)

0/21 (0.00%)

0/22 (0.00%)

# events

Gastrointestinal disorders

Diarrhoea¹,^†

# participants affected / at risk

1/23 (4.35%)

1/20 (5.00%)

1/24 (4.17%)

0/22 (0.00%)

1/21 (4.76%)

0/22 (0.00%)

# events

Gastrointestinal disorders

Diverticulum intestinal¹,^†

# participants affected / at risk

0/23 (0.00%)

0/20 (0.00%)

0/24 (0.00%)

0/22 (0.00%)

1/21 (4.76%)

0/22 (0.00%)

# events

Gastrointestinal disorders

Dyspepsia¹,^†

# participants affected / at risk

0/23 (0.00%)

0/20 (0.00%)

0/24 (0.00%)

0/22 (0.00%)

1/21 (4.76%)

0/22 (0.00%)

# events

Gastrointestinal disorders

Flatulence¹,^†

# participants affected / at risk

0/23 (0.00%)

1/20 (5.00%)

0/24 (0.00%)

0/22 (0.00%)

0/21 (0.00%)

0/22 (0.00%)

# events

Gastrointestinal disorders

Gastrooesophageal reflux disease¹,^†

# participants affected / at risk

1/23 (4.35%)

0/20 (0.00%)

0/24 (0.00%)

0/22 (0.00%)

1/21 (4.76%)

0/22 (0.00%)

# events

Gastrointestinal disorders

Nausea¹,^†

# participants affected / at risk

1/23 (4.35%)

0/20 (0.00%)

1/24 (4.17%)

0/22 (0.00%)

1/21 (4.76%)

1/22 (4.55%)

# events

Gastrointestinal disorders

Pancreatic cyst¹,^†

# participants affected / at risk

0/23 (0.00%)

0/20 (0.00%)

0/24 (0.00%)

0/22 (0.00%)

1/21 (4.76%)

0/22 (0.00%)

# events

Gastrointestinal disorders

Vomiting¹,^†

# participants affected / at risk

0/23 (0.00%)

1/20 (5.00%)

1/24 (4.17%)

0/22 (0.00%)

0/21 (0.00%)

0/22 (0.00%)

# events

General disorders and administration site conditions

Influenza like illness¹,^†

# participants affected / at risk

0/23 (0.00%)

0/20 (0.00%)

0/24 (0.00%)

0/22 (0.00%)

0/21 (0.00%)

1/22 (4.55%)

# events

General disorders and administration site conditions

Injection site bruising¹,^†

# participants affected / at risk

2/23 (8.70%)

0/20 (0.00%)

0/24 (0.00%)

0/22 (0.00%)

1/21 (4.76%)

1/22 (4.55%)

# events

General disorders and administration site conditions

Injection site erythema¹,^†

# participants affected / at risk

2/23 (8.70%)

0/20 (0.00%)

1/24 (4.17%)

3/22 (13.64%)

4/21 (19.05%)

0/22 (0.00%)

# events

General disorders and administration site conditions

Injection site swelling¹,^†

# participants affected / at risk

0/23 (0.00%)

0/20 (0.00%)

0/24 (0.00%)

1/22 (4.55%)

0/21 (0.00%)

0/22 (0.00%)

# events

General disorders and administration site conditions

Non-cardiac chest pain¹,^†

# participants affected / at risk

0/23 (0.00%)

0/20 (0.00%)

0/24 (0.00%)

0/22 (0.00%)

1/21 (4.76%)

0/22 (0.00%)

# events

General disorders and administration site conditions

Oedema peripheral¹,^†

# participants affected / at risk

0/23 (0.00%)

0/20 (0.00%)

0/24 (0.00%)

0/22 (0.00%)

0/21 (0.00%)

1/22 (4.55%)

# events

Hepatobiliary disorders

Cholelithiasis¹,^†

# participants affected / at risk

0/23 (0.00%)

0/20 (0.00%)

0/24 (0.00%)

0/22 (0.00%)

1/21 (4.76%)

0/22 (0.00%)

# events

Infections and infestations

Fungal skin infection¹,^†

# participants affected / at risk

0/23 (0.00%)

0/20 (0.00%)

0/24 (0.00%)

0/22 (0.00%)

1/21 (4.76%)

0/22 (0.00%)

# events

Infections and infestations

Furuncle¹,^†

# participants affected / at risk

0/23 (0.00%)

0/20 (0.00%)

0/24 (0.00%)

0/22 (0.00%)

1/21 (4.76%)

0/22 (0.00%)

# events

Infections and infestations

Gastroenteritis viral¹,^†

# participants affected / at risk

0/23 (0.00%)

1/20 (5.00%)

1/24 (4.17%)

0/22 (0.00%)

0/21 (0.00%)

0/22 (0.00%)

# events

Infections and infestations

Gastrointestinal infection¹,^†

# participants affected / at risk

0/23 (0.00%)

0/20 (0.00%)

0/24 (0.00%)

1/22 (4.55%)

0/21 (0.00%)

0/22 (0.00%)

# events

Infections and infestations

Hordeolum¹,^†

# participants affected / at risk

0/23 (0.00%)

0/20 (0.00%)

0/24 (0.00%)

0/22 (0.00%)

1/21 (4.76%)

0/22 (0.00%)

# events

Infections and infestations

Infected dermal cyst¹,^†

# participants affected / at risk

0/23 (0.00%)

0/20 (0.00%)

0/24 (0.00%)

0/22 (0.00%)

2/21 (9.52%)

0/22 (0.00%)

# events

Infections and infestations

Nasopharyngitis¹,^†

# participants affected / at risk

1/23 (4.35%)

1/20 (5.00%)

0/24 (0.00%)

0/22 (0.00%)

1/21 (4.76%)

1/22 (4.55%)

# events

Infections and infestations

Sinusitis¹,^†

# participants affected / at risk

0/23 (0.00%)

0/20 (0.00%)

0/24 (0.00%)

0/22 (0.00%)

0/21 (0.00%)

1/22 (4.55%)

# events

Infections and infestations

Tooth infection¹,^†

# participants affected / at risk

0/23 (0.00%)

0/20 (0.00%)

0/24 (0.00%)

0/22 (0.00%)

0/21 (0.00%)

1/22 (4.55%)

# events

Infections and infestations

Upper respiratory tract infection¹,^†

# participants affected / at risk

0/23 (0.00%)

1/20 (5.00%)

1/24 (4.17%)

1/22 (4.55%)

0/21 (0.00%)

2/22 (9.09%)

# events

Infections and infestations

Urinary tract infection¹,^†

# participants affected / at risk

0/23 (0.00%)

1/20 (5.00%)

0/24 (0.00%)

0/22 (0.00%)

2/21 (9.52%)

0/22 (0.00%)

# events

Infections and infestations

Viral upper respiratory tract infection¹,^†

# participants affected / at risk

0/23 (0.00%)

0/20 (0.00%)

0/24 (0.00%)

0/22 (0.00%)

0/21 (0.00%)

1/22 (4.55%)

# events

Injury, poisoning and procedural complications

Contusion¹,^†

# participants affected / at risk

0/23 (0.00%)

0/20 (0.00%)

0/24 (0.00%)

0/22 (0.00%)

2/21 (9.52%)

0/22 (0.00%)

# events

Injury, poisoning and procedural complications

Muscle strain¹,^†

# participants affected / at risk

0/23 (0.00%)

0/20 (0.00%)

0/24 (0.00%)

0/22 (0.00%)

2/21 (9.52%)

0/22 (0.00%)

# events

Injury, poisoning and procedural complications

Road traffic accident¹,^†

# participants affected / at risk

0/23 (0.00%)

0/20 (0.00%)

0/24 (0.00%)

0/22 (0.00%)

0/21 (0.00%)

1/22 (4.55%)

# events

Investigations

Apolipoprotein b increased¹,^†

# participants affected / at risk

1/23 (4.35%)

1/20 (5.00%)

1/24 (4.17%)

0/22 (0.00%)

1/21 (4.76%)

0/22 (0.00%)

# events

Investigations

Blood triglycerides increased¹,^†

# participants affected / at risk

0/23 (0.00%)

0/20 (0.00%)

0/24 (0.00%)

1/22 (4.55%)

0/21 (0.00%)

0/22 (0.00%)

# events

Investigations

Crystal urine present¹,^†

# participants affected / at risk

0/23 (0.00%)

0/20 (0.00%)

0/24 (0.00%)

1/22 (4.55%)

0/21 (0.00%)

0/22 (0.00%)

# events

Investigations

Liver function test increased¹,^†

# participants affected / at risk

0/23 (0.00%)

1/20 (5.00%)

0/24 (0.00%)

0/22 (0.00%)

0/21 (0.00%)

0/22 (0.00%)

# events

Investigations

Prostatic specific antigen increased¹,^†

# participants affected / at risk

0/23 (0.00%)

0/20 (0.00%)

0/24 (0.00%)

0/22 (0.00%)

1/21 (4.76%)

0/22 (0.00%)

# events

Metabolism and nutrition disorders

Hyperglycaemia¹,^†

# participants affected / at risk

0/23 (0.00%)

1/20 (5.00%)

0/24 (0.00%)

0/22 (0.00%)

0/21 (0.00%)

0/22 (0.00%)

# events

Metabolism and nutrition disorders

Hyperkalaemia¹,^†

# participants affected / at risk

0/23 (0.00%)

1/20 (5.00%)

0/24 (0.00%)

0/22 (0.00%)

0/21 (0.00%)

0/22 (0.00%)

# events

Metabolism and nutrition disorders

Hypertriglyceridaemia¹,^†

# participants affected / at risk

0/23 (0.00%)

1/20 (5.00%)

0/24 (0.00%)

0/22 (0.00%)

0/21 (0.00%)

1/22 (4.55%)

# events

Metabolism and nutrition disorders

Type 2 diabetes mellitus¹,^†

# participants affected / at risk

1/23 (4.35%)

0/20 (0.00%)

0/24 (0.00%)

0/22 (0.00%)

1/21 (4.76%)

0/22 (0.00%)

# events

Musculoskeletal and connective tissue disorders

Arthralgia¹,^†

# participants affected / at risk

1/23 (4.35%)

2/20 (10.00%)

0/24 (0.00%)

0/22 (0.00%)

0/21 (0.00%)

0/22 (0.00%)

# events

Musculoskeletal and connective tissue disorders

Arthritis¹,^†

# participants affected / at risk

0/23 (0.00%)

0/20 (0.00%)

0/24 (0.00%)

1/22 (4.55%)

0/21 (0.00%)

0/22 (0.00%)

# events

Musculoskeletal and connective tissue disorders

Back pain¹,^†

# participants affected / at risk

0/23 (0.00%)

0/20 (0.00%)

0/24 (0.00%)

0/22 (0.00%)

1/21 (4.76%)

1/22 (4.55%)

# events

Musculoskeletal and connective tissue disorders

Flank pain¹,^†

# participants affected / at risk

0/23 (0.00%)

0/20 (0.00%)

0/24 (0.00%)

0/22 (0.00%)

1/21 (4.76%)

0/22 (0.00%)

# events

Musculoskeletal and connective tissue disorders

Intervertebral disc degeneration¹,^†

# participants affected / at risk

0/23 (0.00%)

0/20 (0.00%)

0/24 (0.00%)

1/22 (4.55%)

1/21 (4.76%)

0/22 (0.00%)

# events

Musculoskeletal and connective tissue disorders

Muscle spasms¹,^†

# participants affected / at risk

0/23 (0.00%)

0/20 (0.00%)

0/24 (0.00%)

1/22 (4.55%)

0/21 (0.00%)

0/22 (0.00%)

# events

Musculoskeletal and connective tissue disorders

Musculoskeletal pain¹,^†

# participants affected / at risk

2/23 (8.70%)

0/20 (0.00%)

0/24 (0.00%)

0/22 (0.00%)

0/21 (0.00%)

0/22 (0.00%)

# events

Musculoskeletal and connective tissue disorders

Musculoskeletal stiffness¹,^†

# participants affected / at risk

0/23 (0.00%)

0/20 (0.00%)

0/24 (0.00%)

0/22 (0.00%)

0/21 (0.00%)

1/22 (4.55%)

# events

Musculoskeletal and connective tissue disorders

Osteoarthritis¹,^†

# participants affected / at risk

0/23 (0.00%)

0/20 (0.00%)

0/24 (0.00%)

0/22 (0.00%)

1/21 (4.76%)

0/22 (0.00%)

# events

Musculoskeletal and connective tissue disorders

Pain in extremity¹,^†

# participants affected / at risk

0/23 (0.00%)

0/20 (0.00%)

0/24 (0.00%)

0/22 (0.00%)

1/21 (4.76%)

0/22 (0.00%)

# events

Musculoskeletal and connective tissue disorders

Tendonitis¹,^†

# participants affected / at risk

0/23 (0.00%)

0/20 (0.00%)

0/24 (0.00%)

0/22 (0.00%)

1/21 (4.76%)

0/22 (0.00%)

# events

Neoplasms benign, malignant and unspecified (incl cysts and polyps)

Basal cell carcinoma¹,^†

# participants affected / at risk

0/23 (0.00%)

0/20 (0.00%)

0/24 (0.00%)

1/22 (4.55%)

0/21 (0.00%)

0/22 (0.00%)

# events

Nervous system disorders

Restless legs syndrome¹,^†

# participants affected / at risk

0/23 (0.00%)

0/20 (0.00%)

0/24 (0.00%)

0/22 (0.00%)

1/21 (4.76%)

0/22 (0.00%)

# events

Nervous system disorders

Syncope¹,^†

# participants affected / at risk

0/23 (0.00%)

0/20 (0.00%)

0/24 (0.00%)

1/22 (4.55%)

0/21 (0.00%)

0/22 (0.00%)

# events

Renal and urinary disorders

Calculus bladder¹,^†

# participants affected / at risk

0/23 (0.00%)

0/20 (0.00%)

0/24 (0.00%)

0/22 (0.00%)

0/21 (0.00%)

1/22 (4.55%)

# events

Renal and urinary disorders

Haematuria¹,^†

# participants affected / at risk

0/23 (0.00%)

0/20 (0.00%)

0/24 (0.00%)

0/22 (0.00%)

1/21 (4.76%)

1/22 (4.55%)

# events

Renal and urinary disorders

Neurogenic bladder¹,^†

# participants affected / at risk

0/23 (0.00%)

0/20 (0.00%)

0/24 (0.00%)

0/22 (0.00%)

1/21 (4.76%)

0/22 (0.00%)

# events

Renal and urinary disorders

Nocturia¹,^†

# participants affected / at risk

0/23 (0.00%)

0/20 (0.00%)

0/24 (0.00%)

0/22 (0.00%)

1/21 (4.76%)

0/22 (0.00%)

# events

Renal and urinary disorders

Renal cyst¹,^†

# participants affected / at risk

0/23 (0.00%)

0/20 (0.00%)

0/24 (0.00%)

0/22 (0.00%)

1/21 (4.76%)

0/22 (0.00%)

# events

Renal and urinary disorders

Urine flow decreased¹,^†

# participants affected / at risk

0/23 (0.00%)

0/20 (0.00%)

0/24 (0.00%)

0/22 (0.00%)

1/21 (4.76%)

0/22 (0.00%)

# events

Reproductive system and breast disorders

Benign prostatic hyperplasia¹,^†

# participants affected / at risk

0/23 (0.00%)

0/20 (0.00%)

0/24 (0.00%)

0/22 (0.00%)

1/21 (4.76%)

0/22 (0.00%)

# events

Reproductive system and breast disorders

Nipple pain¹,^†

# participants affected / at risk

0/23 (0.00%)

0/20 (0.00%)

0/24 (0.00%)

0/22 (0.00%)

1/21 (4.76%)

0/22 (0.00%)

# events

Respiratory, thoracic and mediastinal disorders

Allergic cough¹,^†

# participants affected / at risk

0/23 (0.00%)

0/20 (0.00%)

0/24 (0.00%)

0/22 (0.00%)

1/21 (4.76%)

0/22 (0.00%)

# events

Respiratory, thoracic and mediastinal disorders

Chronic obstructive pulmonary disease¹,^†

# participants affected / at risk

1/23 (4.35%)

0/20 (0.00%)

0/24 (0.00%)

0/22 (0.00%)

0/21 (0.00%)

1/22 (4.55%)

# events

Respiratory, thoracic and mediastinal disorders

Nasal congestion¹,^†

# participants affected / at risk

0/23 (0.00%)

0/20 (0.00%)

0/24 (0.00%)

0/22 (0.00%)

0/21 (0.00%)

1/22 (4.55%)

# events

Respiratory, thoracic and mediastinal disorders

Pulmonary mass¹,^†

# participants affected / at risk

1/23 (4.35%)

0/20 (0.00%)

0/24 (0.00%)

0/22 (0.00%)

1/21 (4.76%)

0/22 (0.00%)

# events

Respiratory, thoracic and mediastinal disorders

Sinus congestion¹,^†

# participants affected / at risk

0/23 (0.00%)

0/20 (0.00%)

0/24 (0.00%)

0/22 (0.00%)

0/21 (0.00%)

1/22 (4.55%)

# events

Skin and subcutaneous tissue disorders

Angioedema¹,^†

# participants affected / at risk

0/23 (0.00%)

0/20 (0.00%)

0/24 (0.00%)

0/22 (0.00%)

1/21 (4.76%)

0/22 (0.00%)

# events

Skin and subcutaneous tissue disorders

Dermal cyst¹,^†

# participants affected / at risk

0/23 (0.00%)

0/20 (0.00%)

0/24 (0.00%)

1/22 (4.55%)

0/21 (0.00%)

0/22 (0.00%)

# events

Skin and subcutaneous tissue disorders

Dermatitis contact¹,^†

# participants affected / at risk

1/23 (4.35%)

0/20 (0.00%)

0/24 (0.00%)

1/22 (4.55%)

0/21 (0.00%)

0/22 (0.00%)

# events

Skin and subcutaneous tissue disorders

Skin ulcer¹,^†

# participants affected / at risk

0/23 (0.00%)

0/20 (0.00%)

0/24 (0.00%)

1/22 (4.55%)

0/21 (0.00%)

0/22 (0.00%)

# events

Vascular disorders

Hypotension¹,^†

# participants affected / at risk

1/23 (4.35%)

2/20 (10.00%)

0/24 (0.00%)

0/22 (0.00%)

0/21 (0.00%)

0/22 (0.00%)

# events

†	Events were collected by systematic assessment
1	Term from vocabulary, MedDRA 21
2	Term from vocabulary, MedDRA 21.0

Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.

The agreement is:

	The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is less than or equal to 60 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
	The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is more than 60 days but less than or equal to 180 days . The sponsor cannot require changes to the communication and cannot extend the embargo.
	Other disclosure agreement that restricts the right of the PI to discuss or publish trial results after the trial is completed. Restriction Description: MedImmune has 60 days to review results communications prior to public release and may delete information that compromises on going studies or is considered proprietary. This restriction is not intended to compromise the objective scientific integrity of the manuscript, it being understood that results shall be published regardless of outcome.

Limitations and Caveats

Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
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Results Point of Contact

Name/Title:	Richard George
Organization:	MedImmune, LLC
Phone	+1-301-398-5681
E-mail:	[email protected]

Documents available

D7870C00002 Clinical Protocol Redacted
Download
D7870C00002 Statistical Analysis Plan Redacted
Download
Trial Results Summaries
Available here

Contacts

Contact

AstraZeneca Clinical Study Information Center

1-877-240-9479

information.center@astrazeneca.com

Investigators

Principal Investigator

Michael J Koren

Jacksonville Center for Clinical Research

Sponsors

Collaborators

Inclusion Criteria

Exclusion Criteria

Research Site

Research Site

Research Site

Research Site

Research Site

Research Site

Research Site

Research Site

D7870C00002 Clinical Protocol Redacted

D7870C00002 Statistical Analysis Plan Redacted

Trial Results Summaries