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
-
No locations available
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 |