Study identifier:D9230C00001
ClinicalTrials.gov identifier:NCT05143905
EudraCT identifier:N/A
CTIS identifier:N/A
A Phase I Randomised Single-blind Placebo-controlled Study to Assess the Safety, Tolerability and Pharmacokinetics of AZD7503 Following Single Ascending Dose Administration to Healthy Participants
Safety, Healthy Participants
Phase 1
Yes
AZD7503, Placebo
All
56
Interventional
18 Years - 65 Years
Allocation: Randomized
Endpoint Classification: -
Intervention Model: Sequential Assignment
Masking: -
Primary Purpose: Treatment
Verified 01 Nov 2022 by AstraZeneca
AstraZeneca
-
No locations available
Arms | Assigned Interventions |
---|---|
Experimental: Cohort 1: AZD7503 dose 1 Randomised healthy participants will receive a single dose 1 of AZD7503. | Drug: AZD7503 Randomised participants will receive a single ascending dose of AZD7503 by SC injection (dose 1, dose 2, dose 3, dose 4, dose X and dose Y). |
Experimental: Cohort 2: AZD7503 dose 2 Randomised healthy participants will receive a single dose 2 of AZD7503. | Drug: AZD7503 Randomised participants will receive a single ascending dose of AZD7503 by SC injection (dose 1, dose 2, dose 3, dose 4, dose X and dose Y). |
Experimental: Cohort 3: AZD7503 dose 3 Randomised healthy participants will receive a single dose 3 of AZD7503. | Drug: AZD7503 Randomised participants will receive a single ascending dose of AZD7503 by SC injection (dose 1, dose 2, dose 3, dose 4, dose X and dose Y). |
Experimental: Cohort 4: AZD7503 dose 4 Randomised healthy participants will receive a single dose 4 of AZD7503. | Drug: AZD7503 Randomised participants will receive a single ascending dose of AZD7503 by SC injection (dose 1, dose 2, dose 3, dose 4, dose X and dose Y). |
Experimental: Cohort 5 : AZD7503 dose X Randomised healthy participants will receive a single dose X of AZD7503. | Drug: AZD7503 Randomised participants will receive a single ascending dose of AZD7503 by SC injection (dose 1, dose 2, dose 3, dose 4, dose X and dose Y). |
Experimental: Cohort 6: AZD7503 dose Y Randomised healthy participants will receive a single dose Y of AZD7503. | Drug: AZD7503 Randomised participants will receive a single ascending dose of AZD7503 by SC injection (dose 1, dose 2, dose 3, dose 4, dose X and dose Y). |
Placebo Comparator: Pooled Placebo for AZD7503 (Cohorts 1 to 6) Randomised healthy participants will receive placebo. | Drug: Placebo Randomised participants will receive placebo by SC injection |
Experimental: Japanese Cohort 1: AZD7503 dose 3 Randomised healthy Japanese participants will receive a single dose 3 of AZD7503. | Drug: AZD7503 Randomised participants will receive a single ascending dose of AZD7503 by SC injection (dose 1, dose 2, dose 3, dose 4, dose X and dose Y). |
Experimental: Japanese Cohort 2: AZD7503 dose 4 Randomised healthy Japanese participants will receive a single dose 4 of AZD7503. | Drug: AZD7503 Randomised participants will receive a single ascending dose of AZD7503 by SC injection (dose 1, dose 2, dose 3, dose 4, dose X and dose Y). |
Placebo Comparator: Placebo (Japanese Cohorts) Randomised healthy Japanese participants will receive placebo. | Drug: Placebo Randomised participants will receive placebo by SC injection |
Experimental: Chinese Cohort: AZD7503 dose 4 Randomised healthy Chinese participants will receive a single dose 4 of AZD7503. | Drug: AZD7503 Randomised participants will receive a single ascending dose of AZD7503 by SC injection (dose 1, dose 2, dose 3, dose 4, dose X and dose Y). |
Placebo Comparator: Placebo (Chinese Cohort) Randomised healthy Chinese participants will receive placebo. | Drug: Placebo Randomised participants will receive placebo by SC injection |