Study identifier:D7060C00002
ClinicalTrials.gov identifier:NCT05714254
EudraCT identifier:2022-002889-32
CTIS identifier:N/A
A Randomised, Double-blind, Placebo-controlled Study of the Safety, Tolerability, and Pharmacokinetics of Multiple Ascending Doses of MEDI0618 in Healthy Male and Female Volunteers
Chronic Pain
Phase 1
Yes
MEDI0618
All
36
Interventional
18 Years - 50 Years
Allocation: Randomized
Endpoint Classification: -
Intervention Model: Parallel Assignment
Masking: -
Primary Purpose: Other
Verified 01 Dec 2024 by AstraZeneca
AstraZeneca
-
This is a single centre, randomised, double-blind, placebo-controlled, multiple ascending dose study of MEDI0618 in healthy male and female volunteers. Participants will receive MEDI0618 or placebo administered by intravenous infusion or subcutaneous injection. Safety, tolerability, and pharmacokinetics of multiple ascending doses of MEDI0618 will be assessed.
Location
Location
Berlin, Germany, 10117
Arms | Assigned Interventions |
---|---|
Experimental: Cohort 1: MEDI0618 Dose Level 1 Participants will receive 4 doses of intravenous (IV) infusion of MEDl0618 Dose Level 1 on Days 1, 15, 29, and 43 during 8-week treatment period. | Drug: MEDI0618 Participants will receive IV infusion or SC injection of MEDI0618 as stated in arm description. Other Name: Protease-Activated Receptor 2 Antagonist |
Experimental: Cohort 2: MEDI0618 Dose Level 2 Participants will receive 4 doses of IV infusion of MEDl0618 Dose Level 2 on Days 1, 15, 29, and 43 during 8-week treatment period. | Drug: MEDI0618 Participants will receive IV infusion or SC injection of MEDI0618 as stated in arm description. Other Name: Protease-Activated Receptor 2 Antagonist |
Placebo Comparator: Cohort 1-2: Placebo Participants will receive 4 doses of IV infusion of placebo matched to Dose Level 1 and 2 (4 participants in each dose level) on Days 1, 15, 29, and 43 during 8-week treatment period. | Other: Placebo Participants will receive IV infusion or SC injection of placebo as stated in arm description. Other Name: Placebo |
Experimental: Cohort 3: MEDI0618 Dose Level 2 Participants will receive 4 doses of subcutaneous (SC) injection of MEDl0618 Dose Level 2 on Days 1, 15, 29, and 43 during 8-week treatment period. | Drug: MEDI0618 Participants will receive IV infusion or SC injection of MEDI0618 as stated in arm description. Other Name: Protease-Activated Receptor 2 Antagonist |
Placebo Comparator: Cohort 3: Placebo Participants will receive 4 doses of SC injection of placebo matched to Dose Level 2 on Days 1, 15, 29, and 43 during 8-week treatment period. | Other: Placebo Participants will receive IV infusion or SC injection of placebo as stated in arm description. Other Name: Placebo |
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