A Study to Evaluate the Safety of MEDI2338 in Subjects with Chronic Obstructive Pulmonary Disease

Study identifier:CD-RI-MEDI2338-1033

ClinicalTrials.gov identifier:N/A

EudraCT identifier:2010-022879-54

CTIS identifier:N/A

Study Complete

Official Title

A Phase 1, Single Ascending Dose Study to Evaluate the Safety of MEDI2338 in Subjects with Chronic Obstructive Pulmonary Disease

Medical condition

Chronic Obstructive Pulmonary Disease

Phase

Phase 1

Healthy volunteers

Study drug

Sex

All

Actual Enrollment

Study type

Interventional

Age

40 Years - 99 Years

Date

Study Start Date: 01 Mar 2011

Primary Completion Date: 01 Nov 2011

Study Completion Date: 01 Dec 2011

Study design

Allocation: Randomized
Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: Single Blind
Primary Purpose: Treatment

Verification:

Verified 01 Oct 2013 by MedImmune, LLC

Collaborators

Inclusion and exclusion criteria

Location

Research Site

Harrow, United Kingdom, HA1 3UJ

Location

Research Site

Port Elizabeth, South Africa, 6045

Location

Research Site

George, South Africa, 6529

Location

Research Site

Bloemfontein , South Africa, 9300

Arms	Assigned Interventions
Experimental: MEDI2338 10 MG MEDI2338 (10 mg) administered as a single, fixed intravenous (IV) dose over a minimum of 60 minutes using an infusion pump	Biological/Vaccine: MEDI2338 MEDI2338 single intravenous (IV) dose (lowest dose)
Experimental: MEDI2338 30 MG MEDI2338 (30 mg) administered as a single, fixed IV dose over a minimum of 60 minutes using an infusion pump	Biological/Vaccine: MEDI2338 MEDI2338 single IV dose (next highest dose)
Experimental: MEDI2338 100 MG MEDI2338 (100 mg) administered as a single, fixed IV dose over a minimum of 60 minutes using an infusion pump	Biological/Vaccine: MEDI2338 MEDI2338 single IV dose (next highest dose)
Experimental: MEDI2338 300 MG MEDI2338 (300 mg) administered as a single, fixed IV dose over a minimum of 60 minutes using an infusion pump	Biological/Vaccine: MEDI2338 MEDI2338 single IV dose (next highest dose)
Experimental: MEDI2338 1000 MG MEDI2338 (1000 mg) administered as a single, fixed IV dose over a minimum of 60 minutes using an infusion pump	Biological/Vaccine: MEDI2338 MEDI2338 single IV dose (highest dose)
Placebo Comparator: Placebo Placebo administered as a single, fixed IV dose over a minimum of 60 minutes using an infusion pump	Other: Placebo Placebo single IV dose

Participant Flow

Recruitment Details

Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
A total of 31 participants provided written informed consent and participated in the study at 3 sites in South Africa (2 sites) and the United Kingdom (1 site) between 24Feb2011 and 25Nov2011.

Pre-Assignment Details

Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
Eligibile participants in the 10 and 30 mg dose groups received MEDI2338 in an open-label manner. Eligible participants in the 100, 300, and 1000 dose groups were randomized in a 3:1 ratio to receive MEDI2338 or placebo.

Reporting Groups

	Description
Placebo	Placebo administered as a single, fixed IV dose over a minimum of 60 minutes using an infusion pump
MEDI2338 10 MG	MEDI2338 (10 mg) administered as a single, fixed intravenous (IV) dose over a minimum of 60 minutes using an infusion pump
MEDI2338 30 MG	MEDI2338 (30 mg) administered as a single, fixed IV dose over a minimum of 60 minutes using an infusion pump
MEDI2338 100 MG	MEDI2338 (100 mg) administered as a single, fixed IV dose over a minimum of 60 minutes using an infusion pump
MEDI2338 300 MG	MEDI2338 (300 mg) administered as a single, fixed IV dose over a minimum of 60 minutes using an infusion pump
MEDI2338 1000 MG	MEDI2338 (1000 mg) administered as a single, fixed IV dose over a minimum of 60 minutes using an infusion pump

Participant Flow: Overall Study

	Placebo	MEDI2338 10 MG	MEDI2338 30 MG	MEDI2338 100 MG	MEDI2338 300 MG	MEDI2338 1000 MG
STARTED	6^[1]	3	3	6	7	6
COMPLETED	6	3	3	6	7	6
NOT COMPLETED	0	0	0	0	0	0

[1]	RANDOMIZED SUBJECTS THROUGH STUDY DAY 240-300

Baseline Characteristics

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

Reporting Groups

	Description
Placebo	Placebo administered as a single, fixed IV dose over a minimum of 60 minutes using an infusion pump
MEDI2338 10 MG	MEDI2338 (10 mg) administered as a single, fixed intravenous (IV) dose over a minimum of 60 minutes using an infusion pump
MEDI2338 30 MG	MEDI2338 (30 mg) administered as a single, fixed IV dose over a minimum of 60 minutes using an infusion pump
MEDI2338 100 MG	MEDI2338 (100 mg) administered as a single, fixed IV dose over a minimum of 60 minutes using an infusion pump
MEDI2338 300 MG	MEDI2338 (300 mg) administered as a single, fixed IV dose over a minimum of 60 minutes using an infusion pump
MEDI2338 1000 MG	MEDI2338 (1000 mg) administered as a single, fixed IV dose over a minimum of 60 minutes using an infusion pump

Baseline Measures

	Placebo	MEDI2338 10 MG	MEDI2338 30 MG	MEDI2338 100 MG	MEDI2338 300 MG	MEDI2338 1000 MG	Total
Number of Participants [units: Participants]	6	3	3	6	7	6	31
Age Continuous [units: Years] Mean ± Standard Deviation	61.3 ± 8.0	57.0 ± 4.0	59.7 ± 11.0	60.3 ± 7.1	55.1 ± 5.3	60.8 ± 6.0	59.1 ± 6.8
Gender, Male/Female [units: Participants]
Male	2	2	1	4	5	6	20
Female	4	1	2	2	2	0	11

Outcome Measures

1. Primary Outcome Measure: Incidence of Adverse Events [ Time Frame: Days 1 - 92 ]

Measure Type	Primary
Measure Name	Incidence of Adverse Events
Measure Description	Number of participants experiencing adverse events (includes both adverse events and serious adverse events)
Time Frame	Days 1 - 92
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.
All 31 participants entered into the study received MEDI2338 or placebo and were included in the analysis

Reporting Groups

	Description
MEDI2338 10 MG	MEDI2338 (10 mg) administered as a single, fixed intravenous (IV) dose over a minimum of 60 minutes using an infusion pump
MEDI2338 30 MG	MEDI2338 (30 mg) administered as a single, fixed IV dose over a minimum of 60 minutes using an infusion pump
MEDI2338 100 MG	MEDI2338 (100 mg) administered as a single, fixed IV dose over a minimum of 60 minutes using an infusion pump
MEDI2338 300 MG	MEDI2338 (300 mg) administered as a single, fixed IV dose over a minimum of 60 minutes using an infusion pump
MEDI2338 1000 MG	MEDI2338 (1000 mg) administered as a single, fixed IV dose over a minimum of 60 minutes using an infusion pump
Placebo	Placebo administered as a single, fixed IV dose over a minimum of 60 minutes using an infusion pump

Measured Values

	MEDI2338 10 MG	MEDI2338 30 MG	MEDI2338 100 MG	MEDI2338 300 MG	MEDI2338 1000 MG	Placebo
Number of Participants Analyzed [units:participants]	3	3	6	7	6	6
Incidence of Adverse Events [units: Participants]	3	3	6	7	5	6

No statistical analysis provided for Incidence of Adverse Events

2. Primary Outcome Measure: Incidence of Serious Adverse Events [ Time Frame: Days 1 - 92 ]

Measure Type	Primary
Measure Name	Incidence of Serious Adverse Events
Measure Description	Number of participants experiencing serious adverse events
Time Frame	Days 1 - 92
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.
All 31 participants entered into the study received MEDI2338 or placebo and were included in the analysis

Reporting Groups

	Description
MEDI2338 10 MG	MEDI2338 (10 mg) administered as a single, fixed intravenous (IV) dose over a minimum of 60 minutes using an infusion pump
MEDI2338 30 MG	MEDI2338 (30 mg) administered as a single, fixed IV dose over a minimum of 60 minutes using an infusion pump
MEDI2338 100 MG	MEDI2338 (100 mg) administered as a single, fixed IV dose over a minimum of 60 minutes using an infusion pump
MEDI2338 300 MG	MEDI2338 (300 mg) administered as a single, fixed IV dose over a minimum of 60 minutes using an infusion pump
MEDI2338 1000 MG	MEDI2338 (1000 mg) administered as a single, fixed IV dose over a minimum of 60 minutes using an infusion pump
Placebo	Placebo administered as a single, fixed IV dose over a minimum of 60 minutes using an infusion pump

Measured Values

	MEDI2338 10 MG	MEDI2338 30 MG	MEDI2338 100 MG	MEDI2338 300 MG	MEDI2338 1000 MG	Placebo
Number of Participants Analyzed [units:participants]	3	3	6	7	6	6
Incidence of Serious Adverse Events [units: Participants]	0	0	0	0	0	0

No statistical analysis provided for Incidence of Serious Adverse Events

3. Primary Outcome Measure: Incidence of Clinically Significant Hematology Laboratory Results [ Time Frame: Days 1 - 92 ]

Measure Type	Primary
Measure Name	Incidence of Clinically Significant Hematology Laboratory Results
Measure Description	Number of participants experiencing clinically significant hematology laboratory results. A clinically significant hematology laboratory result is defined as an abnormal hematology laboratory result that results in a treatment-emergent adverse event.
Time Frame	Days 1 - 92
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.
All 31 participants entered into the study received MEDI2338 or placebo and were included in the analysis

Reporting Groups

	Description
MEDI2338 10 MG	MEDI2338 (10 mg) administered as a single, fixed intravenous (IV) dose over a minimum of 60 minutes using an infusion pump
MEDI2338 30 MG	MEDI2338 (30 mg) administered as a single, fixed IV dose over a minimum of 60 minutes using an infusion pump
MEDI2338 100 MG	MEDI2338 (100 mg) administered as a single, fixed IV dose over a minimum of 60 minutes using an infusion pump
MEDI2338 300 MG	MEDI2338 (300 mg) administered as a single, fixed IV dose over a minimum of 60 minutes using an infusion pump
MEDI2338 1000 MG	MEDI2338 (1000 mg) administered as a single, fixed IV dose over a minimum of 60 minutes using an infusion pump
Placebo	Placebo administered as a single, fixed IV dose over a minimum of 60 minutes using an infusion pump

Measured Values

	MEDI2338 10 MG	MEDI2338 30 MG	MEDI2338 100 MG	MEDI2338 300 MG	MEDI2338 1000 MG	Placebo
Number of Participants Analyzed [units:participants]	3	3	6	7	6	6
Incidence of Clinically Significant Hematology Laboratory Results [units: Participants]	0	0	0	0	0	0

No statistical analysis provided for Incidence of Clinically Significant Hematology Laboratory Results

4. Primary Outcome Measure: Incidence of Clinically Significant Electrocardiogram Results [ Time Frame: Days 1 - 92 ]

Measure Type	Primary
Measure Name	Incidence of Clinically Significant Electrocardiogram Results
Measure Description	Number of participants experiencing clinically significant electrocardiogram results. A clinically significant electrocardiogram result is defined as an abnormal electrocardiogram result that results in a treatment-emergent adverse event.
Time Frame	Days 1 - 92
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.
All 31 participants entered into the study received MEDI2338 or placebo and were included in the analysis

Reporting Groups

	Description
MEDI2338 10 MG	MEDI2338 (10 mg) administered as a single, fixed intravenous (IV) dose over a minimum of 60 minutes using an infusion pump
MEDI2338 30 MG	MEDI2338 (30 mg) administered as a single, fixed IV dose over a minimum of 60 minutes using an infusion pump
MEDI2338 100 MG	MEDI2338 (100 mg) administered as a single, fixed IV dose over a minimum of 60 minutes using an infusion pump
MEDI2338 300 MG	MEDI2338 (300 mg) administered as a single, fixed IV dose over a minimum of 60 minutes using an infusion pump
MEDI2338 1000 MG	MEDI2338 (1000 mg) administered as a single, fixed IV dose over a minimum of 60 minutes using an infusion pump
Placebo	Placebo administered as a single, fixed IV dose over a minimum of 60 minutes using an infusion pump

Measured Values

	MEDI2338 10 MG	MEDI2338 30 MG	MEDI2338 100 MG	MEDI2338 300 MG	MEDI2338 1000 MG	Placebo
Number of Participants Analyzed [units:participants]	3	3	6	7	6	6
Incidence of Clinically Significant Electrocardiogram Results [units: Participants]	0	0	0	0	0	1

No statistical analysis provided for Incidence of Clinically Significant Electrocardiogram Results

5. Primary Outcome Measure: Incidence of Clinically Significant Vital Signs Results [ Time Frame: Days 1 - 92 ]

Measure Type	Primary
Measure Name	Incidence of Clinically Significant Vital Signs Results
Measure Description	Number of participants experiencing clinically significant vital signs results. A clinically significant vital signs result is defined as an abnormal vital signs result that results in a treatment-emergent adverse event.
Time Frame	Days 1 - 92
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.
All 31 participants entered into the study received MEDI2338 or placebo and were included in the analysis

Reporting Groups

	Description
MEDI2338 10 MG	MEDI2338 (10 mg) administered as a single, fixed intravenous (IV) dose over a minimum of 60 minutes using an infusion pump
MEDI2338 30 MG	MEDI2338 (30 mg) administered as a single, fixed IV dose over a minimum of 60 minutes using an infusion pump
MEDI2338 100 MG	MEDI2338 (100 mg) administered as a single, fixed IV dose over a minimum of 60 minutes using an infusion pump
MEDI2338 300 MG	MEDI2338 (300 mg) administered as a single, fixed IV dose over a minimum of 60 minutes using an infusion pump
MEDI2338 1000 MG	MEDI2338 (1000 mg) administered as a single, fixed IV dose over a minimum of 60 minutes using an infusion pump
Placebo	Placebo administered as a single, fixed IV dose over a minimum of 60 minutes using an infusion pump

Measured Values

	MEDI2338 10 MG	MEDI2338 30 MG	MEDI2338 100 MG	MEDI2338 300 MG	MEDI2338 1000 MG	Placebo
Number of Participants Analyzed [units:participants]	3	3	6	7	6	6
Incidence of Clinically Significant Vital Signs Results [units: Participants]	0	0	0	0	0	0

No statistical analysis provided for Incidence of Clinically Significant Vital Signs Results

6. Primary Outcome Measure: Incidence of Clinically Significant Serum Chemistry Laboratory Results [ Time Frame: Days 1 - 92 ]

Measure Type	Primary
Measure Name	Incidence of Clinically Significant Serum Chemistry Laboratory Results
Measure Description	Number of participants experiencing clinically significant serum chemistry laboratory results. A clinically significant serum chemistry laboratory result is defined as an abnormal serum chemistry laboratory result that results in a treatment-emergent adverse event.
Time Frame	Days 1 - 92
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.
All 31 participants entered into the study received MEDI2338 or placebo and were included in the analysis

Reporting Groups

	Description
MEDI2338 10 MG	MEDI2338 (10 mg) administered as a single, fixed intravenous (IV) dose over a minimum of 60 minutes using an infusion pump
MEDI2338 30 MG	MEDI2338 (30 mg) administered as a single, fixed IV dose over a minimum of 60 minutes using an infusion pump
MEDI2338 100 MG	MEDI2338 (100 mg) administered as a single, fixed IV dose over a minimum of 60 minutes using an infusion pump
MEDI2338 300 MG	MEDI2338 (300 mg) administered as a single, fixed IV dose over a minimum of 60 minutes using an infusion pump
MEDI2338 1000 MG	MEDI2338 (1000 mg) administered as a single, fixed IV dose over a minimum of 60 minutes using an infusion pump
Placebo	Placebo administered as a single, fixed IV dose over a minimum of 60 minutes using an infusion pump

Measured Values

	MEDI2338 10 MG	MEDI2338 30 MG	MEDI2338 100 MG	MEDI2338 300 MG	MEDI2338 1000 MG	Placebo
Number of Participants Analyzed [units:participants]	3	3	6	7	6	6
Incidence of Clinically Significant Serum Chemistry Laboratory Results [units: Participants]	0	0	0	0	0	0

No statistical analysis provided for Incidence of Clinically Significant Serum Chemistry Laboratory Results

7. Secondary Outcome Measure: Area Under the Serum Concentration-Time Curve from Time Zero to Infinity [ Time Frame: Pre-dose (Day 1) and post-dose (Days 1 [end of infusion, and 30 minutes and 1, 3, 8, and 24 hours postinfusion], 2, 3, 5, 8, 10, 15, 22, 29, 36, 43, 57, 71, and 92) ]

Measure Type	Secondary
Measure Name	Area Under the Serum Concentration-Time Curve from Time Zero to Infinity
Measure Description	Area under the serum concentration-time curve from time zerio to infinity of MEDI2338
Time Frame	Pre-dose (Day 1) and post-dose (Days 1 [end of infusion, and 30 minutes and 1, 3, 8, and 24 hours postinfusion], 2, 3, 5, 8, 10, 15, 22, 29, 36, 43, 57, 71, and 92)
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.
Of the 31 participants who entered into the study and received MEDI2338 or placebo, 25 participants received only MEDI2338 and were included in the pharmacokinetic analysis

Reporting Groups

	Description
MEDI2338 10 MG	MEDI2338 (10 mg) administered as a single, fixed intravenous (IV) dose over a minimum of 60 minutes using an infusion pump
MEDI2338 30 MG	MEDI2338 (30 mg) administered as a single, fixed IV dose over a minimum of 60 minutes using an infusion pump
MEDI2338 100 MG	MEDI2338 (100 mg) administered as a single, fixed IV dose over a minimum of 60 minutes using an infusion pump
MEDI2338 300 MG	MEDI2338 (300 mg) administered as a single, fixed IV dose over a minimum of 60 minutes using an infusion pump
MEDI2338 1000 MG	MEDI2338 (1000 mg) administered as a single, fixed IV dose over a minimum of 60 minutes using an infusion pump
Placebo	Placebo administered as a single, fixed IV dose over a minimum of 60 minutes using an infusion pump

Measured Values

	MEDI2338 10 MG	MEDI2338 30 MG	MEDI2338 100 MG	MEDI2338 300 MG	MEDI2338 1000 MG	Placebo
Number of Participants Analyzed [units:participants]	3	3	6	7	6	0
Area Under the Serum Concentration-Time Curve from Time Zero to Infinity [units: ng x day/mL] Mean (Standard Deviation)	27550.5 (8163.6)	104751.1 (40826.2)	281781.5 (61554.1)	915668.6 (342545.7)	3081728.5 (846989.4)

No statistical analysis provided for Area Under the Serum Concentration-Time Curve from Time Zero to Infinity

8. Secondary Outcome Measure: Area Under the Serum Concentration-Time Profile from Time Zero to the Last Measurable Time Point [ Time Frame: Pre-dose (Day 1) and post-dose (Days 1 [end of infusion, and 30 minutes and 1, 3, 8, and 24 hours postinfusion], 2, 3, 5, 8, 10, 15, 22, 29, 36, 43, 57, 71, and 92) ]

Measure Type	Secondary
Measure Name	Area Under the Serum Concentration-Time Profile from Time Zero to the Last Measurable Time Point
Measure Description	Area under the serum concentration-time profile from time zero to the last measurable time point of MEDI2338
Time Frame	Pre-dose (Day 1) and post-dose (Days 1 [end of infusion, and 30 minutes and 1, 3, 8, and 24 hours postinfusion], 2, 3, 5, 8, 10, 15, 22, 29, 36, 43, 57, 71, and 92)
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.
Of the 31 participants who entered into the study and received MEDI2338 or placebo, 25 participants received only MEDI2338 and were included in the pharmacokinetic analysis

Reporting Groups

	Description
MEDI2338 10 MG	MEDI2338 (10 mg) administered as a single, fixed intravenous (IV) dose over a minimum of 60 minutes using an infusion pump
MEDI2338 30 MG	MEDI2338 (30 mg) administered as a single, fixed IV dose over a minimum of 60 minutes using an infusion pump
MEDI2338 100 MG	MEDI2338 (100 mg) administered as a single, fixed IV dose over a minimum of 60 minutes using an infusion pump
MEDI2338 300 MG	MEDI2338 (300 mg) administered as a single, fixed IV dose over a minimum of 60 minutes using an infusion pump
MEDI2338 1000 MG	MEDI2338 (1000 mg) administered as a single, fixed IV dose over a minimum of 60 minutes using an infusion pump
Placebo	Placebo administered as a single, fixed IV dose over a minimum of 60 minutes using an infusion pump

Measured Values

	MEDI2338 10 MG	MEDI2338 30 MG	MEDI2338 100 MG	MEDI2338 300 MG	MEDI2338 1000 MG	Placebo
Number of Participants Analyzed [units:participants]	3	3	6	7	6	0
Area Under the Serum Concentration-Time Profile from Time Zero to the Last Measurable Time Point [units: ng x day/mL] Mean (Standard Deviation)	24427.8 (8086.4)	87549.7 (31391.2)	250155.6 (40613.8)	846433.3 (303849.8)	2909818.8 (812729.7)

No statistical analysis provided for Area Under the Serum Concentration-Time Profile from Time Zero to the Last Measurable Time Point

9. Secondary Outcome Measure: Incidence of Anti-drug Antibodies (ADA) to MEDI2338 [ Time Frame: Days 1, 57, and 92 ]

Measure Type	Secondary
Measure Name	Incidence of Anti-drug Antibodies (ADA) to MEDI2338
Measure Description	Number of participants with ADA to MEDI2338
Time Frame	Days 1, 57, and 92
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.
Of the 31 participants who entered into the study and received MEDI2338 or placebo, 25 participants received only MEDI2338 and were included in the analysis of ADA

Reporting Groups

	Description
MEDI2338 10 MG	MEDI2338 (10 mg) administered as a single, fixed intravenous (IV) dose over a minimum of 60 minutes using an infusion pump
MEDI2338 30 MG	MEDI2338 (30 mg) administered as a single, fixed IV dose over a minimum of 60 minutes using an infusion pump
MEDI2338 100 MG	MEDI2338 (100 mg) administered as a single, fixed IV dose over a minimum of 60 minutes using an infusion pump
MEDI2338 300 MG	MEDI2338 (300 mg) administered as a single, fixed IV dose over a minimum of 60 minutes using an infusion pump
MEDI2338 1000 MG	MEDI2338 (1000 mg) administered as a single, fixed IV dose over a minimum of 60 minutes using an infusion pump
Placebo	Placebo administered as a single, fixed IV dose over a minimum of 60 minutes using an infusion pump

Measured Values

	MEDI2338 10 MG	MEDI2338 30 MG	MEDI2338 100 MG	MEDI2338 300 MG	MEDI2338 1000 MG	Placebo
Number of Participants Analyzed [units:participants]	3	3	6	7	6	0
Incidence of Anti-drug Antibodies (ADA) to MEDI2338 [units: Participants]	0	0	0	0	0

No statistical analysis provided for Incidence of Anti-drug Antibodies (ADA) to MEDI2338

10. Secondary Outcome Measure: Observed Maximum Concentration (Cmax) [ Time Frame: Pre-dose (Day 1) and post-dose (Days 1 [end of infusion, and 30 minutes and 1, 3, 8, and 24 hours postinfusion], 2, 3, 5, 8, 10, 15, 22, 29, 36, 43, 57, 71, and 92) ]

Measure Type	Secondary
Measure Name	Observed Maximum Concentration (Cmax)
Measure Description	Cmax of MEDI2338
Time Frame	Pre-dose (Day 1) and post-dose (Days 1 [end of infusion, and 30 minutes and 1, 3, 8, and 24 hours postinfusion], 2, 3, 5, 8, 10, 15, 22, 29, 36, 43, 57, 71, and 92)
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.
Of the 31 participants who entered into the study and received MEDI2338 or placebo, 25 participants received only MEDI2338 and were included in the pharmacokinetic analysis

Reporting Groups

	Description
MEDI2338 10 MG	MEDI2338 (10 mg) administered as a single, fixed intravenous (IV) dose over a minimum of 60 minutes using an infusion pump
MEDI2338 30 MG	MEDI2338 (30 mg) administered as a single, fixed IV dose over a minimum of 60 minutes using an infusion pump
MEDI2338 100 MG	MEDI2338 (100 mg) administered as a single, fixed IV dose over a minimum of 60 minutes using an infusion pump
MEDI2338 300 MG	MEDI2338 (300 mg) administered as a single, fixed IV dose over a minimum of 60 minutes using an infusion pump
MEDI2338 1000 MG	MEDI2338 (1000 mg) administered as a single, fixed IV dose over a minimum of 60 minutes using an infusion pump
Placebo	Placebo administered as a single, fixed IV dose over a minimum of 60 minutes using an infusion pump

Measured Values

	MEDI2338 10 MG	MEDI2338 30 MG	MEDI2338 100 MG	MEDI2338 300 MG	MEDI2338 1000 MG	Placebo
Number of Participants Analyzed [units:participants]	3	3	6	7	6	0
Observed Maximum Concentration (Cmax) [units: ng/mL] Mean (Standard Deviation)	2458.0 (589.1)	9722.2 (4376.8)	27122.6 (2845.9)	106042.5 (23883.9)	337004.5 (51793.8)

No statistical analysis provided for Observed Maximum Concentration (Cmax)

11. Secondary Outcome Measure: Apparent Terminal Elimination Phase Half-life (t1/2) [ Time Frame: Pre-dose (Day 1) and post-dose (Days 1 [end of infusion, and 30 minutes and 1, 3, 8, and 24 hours postinfusion], 2, 3, 5, 8, 10, 15, 22, 29, 36, 43, 57, 71, and 92) ]

Measure Type	Secondary
Measure Name	Apparent Terminal Elimination Phase Half-life (t1/2)
Measure Description	t1/2 of MEDI2338
Time Frame	Pre-dose (Day 1) and post-dose (Days 1 [end of infusion, and 30 minutes and 1, 3, 8, and 24 hours postinfusion], 2, 3, 5, 8, 10, 15, 22, 29, 36, 43, 57, 71, and 92)
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.
Of the 31 participants who entered into the study and received MEDI2338 or placebo, 25 participants received only MEDI2338 and were included in the pharmacokinetic analysis

Reporting Groups

	Description
MEDI2338 10 MG	MEDI2338 (10 mg) administered as a single, fixed intravenous (IV) dose over a minimum of 60 minutes using an infusion pump
MEDI2338 30 MG	MEDI2338 (30 mg) administered as a single, fixed IV dose over a minimum of 60 minutes using an infusion pump
MEDI2338 100 MG	MEDI2338 (100 mg) administered as a single, fixed IV dose over a minimum of 60 minutes using an infusion pump
MEDI2338 300 MG	MEDI2338 (300 mg) administered as a single, fixed IV dose over a minimum of 60 minutes using an infusion pump
MEDI2338 1000 MG	MEDI2338 (1000 mg) administered as a single, fixed IV dose over a minimum of 60 minutes using an infusion pump
Placebo	Placebo administered as a single, fixed IV dose over a minimum of 60 minutes using an infusion pump

Measured Values

	MEDI2338 10 MG	MEDI2338 30 MG	MEDI2338 100 MG	MEDI2338 300 MG	MEDI2338 1000 MG	Placebo
Number of Participants Analyzed [units:participants]	3	3	6	7	6	0
Apparent Terminal Elimination Phase Half-life (t1/2) [units: Days] Mean (Standard Deviation)	34.85 (5.30)	40.85 (3.51)	28.46 (3.37)	26.76 (5.54)	24.87 (3.27)

No statistical analysis provided for Apparent Terminal Elimination Phase Half-life (t1/2)

12. Secondary Outcome Measure: Clearance (CL) [ Time Frame: Pre-dose (Day 1) and post-dose (Days 1 [end of infusion, and 30 minutes and 1, 3, 8, and 24 hours postinfusion], 2, 3, 5, 8, 10, 15, 22, 29, 36, 43, 57, 71, and 92) ]

Measure Type	Secondary
Measure Name	Clearance (CL)
Measure Description	CL of MEDI2338
Time Frame	Pre-dose (Day 1) and post-dose (Days 1 [end of infusion, and 30 minutes and 1, 3, 8, and 24 hours postinfusion], 2, 3, 5, 8, 10, 15, 22, 29, 36, 43, 57, 71, and 92)
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.
Of the 31 participants who entered into the study and received MEDI2338 or placebo, 25 participants received only MEDI2338 and were included in the pharmacokinetic analysis

Reporting Groups

	Description
MEDI2338 10 MG	MEDI2338 (10 mg) administered as a single, fixed intravenous (IV) dose over a minimum of 60 minutes using an infusion pump
MEDI2338 30 MG	MEDI2338 (30 mg) administered as a single, fixed IV dose over a minimum of 60 minutes using an infusion pump
MEDI2338 100 MG	MEDI2338 (100 mg) administered as a single, fixed IV dose over a minimum of 60 minutes using an infusion pump
MEDI2338 300 MG	MEDI2338 (300 mg) administered as a single, fixed IV dose over a minimum of 60 minutes using an infusion pump
MEDI2338 1000 MG	MEDI2338 (1000 mg) administered as a single, fixed IV dose over a minimum of 60 minutes using an infusion pump
Placebo	Placebo administered as a single, fixed IV dose over a minimum of 60 minutes using an infusion pump

Measured Values

	MEDI2338 10 MG	MEDI2338 30 MG	MEDI2338 100 MG	MEDI2338 300 MG	MEDI2338 1000 MG	Placebo
Number of Participants Analyzed [units:participants]	3	3	6	7	6	0
Clearance (CL) [units: L/Days] Mean (Standard Deviation)	0.387 (0.125)	0.312 (0.099)	0.365 (0.071)	0.360 (0.110)	0.346 (0.097)

No statistical analysis provided for Clearance (CL)

Serious Adverse Events

Time Frame	Days 1-92
Additional Description	No text entered.

Reporting Groups

	Description
Placebo	No text entered.
MEDI2338 10 MG	No text entered.
MEDI2338 30 MG	No text entered.
MEDI2338 100 MG	No text entered.
MEDI2338 300 MG	No text entered.
MEDI2338 1000 MG	No text entered.

Serious Adverse Events

	Placebo	MEDI2338 10 MG	MEDI2338 30 MG	MEDI2338 100 MG	MEDI2338 300 MG	MEDI2338 1000 MG
Total, serious adverse events
# participants affected / at risk	0/6 (0.00%)	0/3 (0.00%)	0/3 (0.00%)	0/6 (0.00%)	0/7 (0.00%)	0/6 (0.00%)

Other Adverse Events

Time Frame	Days 1-92
Additional Description	No text entered.

Frequency Threshold

Threshold above which other adverse events are reported	5%

Reporting Groups

	Description
Placebo	No text entered.
MEDI2338 10 MG	No text entered.
MEDI2338 30 MG	No text entered.
MEDI2338 100 MG	No text entered.
MEDI2338 300 MG	No text entered.
MEDI2338 1000 MG	No text entered.

Other Adverse Events

Placebo

MEDI2338 10 MG

MEDI2338 30 MG

MEDI2338 100 MG

MEDI2338 300 MG

MEDI2338 1000 MG

Total, other (not including serious) adverse events

# participants affected / at risk

6/6 (100.00%)

3/3 (100.00%)

6/6 (100.00%)

7/7 (100.00%)

5/6 (83.33%)

Cardiac disorders

Bradycardia¹,^†

# participants affected / at risk

0/6 (0.00%)

0/3 (0.00%)

2/6 (33.33%)

0/7 (0.00%)

1/6 (16.67%)

# events

Cardiac disorders

Ventricular extrasystoles¹,^†

# participants affected / at risk

1/6 (16.67%)

0/3 (0.00%)

0/6 (0.00%)

1/7 (14.29%)

0/6 (0.00%)

# events

Gastrointestinal disorders

Toothache¹,^†

# participants affected / at risk

0/6 (0.00%)

1/3 (33.33%)

0/3 (0.00%)

1/6 (16.67%)

0/7 (0.00%)

0/6 (0.00%)

# events

Infections and infestations

Nasopharyngitis¹,^†

# participants affected / at risk

0/6 (0.00%)

0/3 (0.00%)

1/3 (33.33%)

0/6 (0.00%)

0/7 (0.00%)

1/6 (16.67%)

# events

Infections and infestations

Sinusitis¹,^†

# participants affected / at risk

2/6 (33.33%)

0/3 (0.00%)

0/6 (0.00%)

0/7 (0.00%)

0/6 (0.00%)

# events

Injury, poisoning and procedural complications

Contusion¹,^†

# participants affected / at risk

1/6 (16.67%)

0/3 (0.00%)

1/3 (33.33%)

0/6 (0.00%)

0/7 (0.00%)

0/6 (0.00%)

# events

Injury, poisoning and procedural complications

Laceration¹,^†

# participants affected / at risk

2/6 (33.33%)

0/3 (0.00%)

0/6 (0.00%)

1/7 (14.29%)

0/6 (0.00%)

# events

Musculoskeletal and connective tissue disorders

Muscle spasms¹,^†

# participants affected / at risk

0/6 (0.00%)

0/3 (0.00%)

1/3 (33.33%)

0/6 (0.00%)

1/7 (14.29%)

0/6 (0.00%)

# events

Nervous system disorders

Dizziness¹,^†

# participants affected / at risk

0/6 (0.00%)

0/3 (0.00%)

1/3 (33.33%)

2/6 (33.33%)

1/7 (14.29%)

1/6 (16.67%)

# events

Nervous system disorders

Headache¹,^†

# participants affected / at risk

1/6 (16.67%)

1/3 (33.33%)

0/3 (0.00%)

2/6 (33.33%)

1/7 (14.29%)

2/6 (33.33%)

# events

Respiratory, thoracic and mediastinal disorders

Chronic obstructive pulmonary disease¹,^†

# participants affected / at risk

0/6 (0.00%)

0/3 (0.00%)

2/3 (66.67%)

1/6 (16.67%)

1/7 (14.29%)

1/6 (16.67%)

# events

Respiratory, thoracic and mediastinal disorders

Cough¹,^†

# participants affected / at risk

0/6 (0.00%)

2/3 (66.67%)

1/3 (33.33%)

0/6 (0.00%)

1/7 (14.29%)

0/6 (0.00%)

# events

Respiratory, thoracic and mediastinal disorders

Nasal congestion¹,^†

# participants affected / at risk

0/6 (0.00%)

1/3 (33.33%)

0/3 (0.00%)

0/6 (0.00%)

1/7 (14.29%)

0/6 (0.00%)

# events

†	Events were collected by systematic assessment
1	Term from vocabulary, MedDRA 14.0

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 ongoing 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. The PIs also agree for data to be presented first as a joint, multi-center publication.

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
No text entered.

Results Point of Contact

Name/Title:	Ed Piper
Organization:	MedImmune, Limited
Phone	+44 (0) 1223 471 471
E-mail:	[email protected]

Documents available

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Trial Results Summaries
Available here

Contacts

Contact

Shaista Parveen

clinicaltrialenquiries@medimmune.com

Investigators

Principal Investigator

Edward Piper

MedImmune Ltd

Sponsors

Collaborators

Inclusion Criteria

Exclusion Criteria

Research Site

Research Site

Research Site

Research Site

Click here and search for drug information provided by the FDA.

Click here and search for information on any recalls, market or product safety alerts by the FDA which might have occurred with this product.

Click here to find results for studies related to marketed products.

Trial Results Summaries