Study identifier:D9090C00001
ClinicalTrials.gov identifier:NCT04994106
EudraCT identifier:N/A
CTIS identifier:N/A
A Phase I Randomized, Single-blind, Placebo-controlled Study to Assess the Safety, Tolerability, and Pharmacokinetics of AZD5462 following Single and Multiple Ascending Dose Administration to Healthy Volunteers
Healthy Participants
Phase 1
Yes
AZD5462, Placebo
All
98
Interventional
18 Years - 50 Years
Allocation: Randomized
Endpoint Classification: -
Intervention Model: Sequential Assignment
Masking: -
Primary Purpose: Other
Verified 01 Nov 2023 by AstraZeneca
AstraZeneca
-
No locations available
Arms | Assigned Interventions |
---|---|
Experimental: Cohort A1: AZD5462 Dose 1 Randomized healthy participants will receive Dose 1 of AZD5462. | Drug: AZD5462 Participants will receive AZD5462, at dose levels of 1 to 5 in part A and at 1 to 4 in part B, respectively. |
Experimental: Cohort A2: AZD5462 Dose 2 Randomized healthy participants will receive Dose 2 of AZD5462. | Drug: AZD5462 Participants will receive AZD5462, at dose levels of 1 to 5 in part A and at 1 to 4 in part B, respectively. |
Experimental: Cohort A3: AZD5462 Dose 3 Randomized healthy participants will receive Dose 3 of AZD5462. | Drug: AZD5462 Participants will receive AZD5462, at dose levels of 1 to 5 in part A and at 1 to 4 in part B, respectively. |
Experimental: Cohort A4 Japanese descent: AZD5462 Dose 3 Randomized participants of Japanese descent will receive Dose 3 of AZD5462. | Drug: AZD5462 Participants will receive AZD5462, at dose levels of 1 to 5 in part A and at 1 to 4 in part B, respectively. |
Experimental: Cohort A5: AZD5462 Dose 4 Randomized healthy participants will receive Dose 4 of AZD5462. | Drug: AZD5462 Participants will receive AZD5462, at dose levels of 1 to 5 in part A and at 1 to 4 in part B, respectively. |
Experimental: Cohort A6 Japanese descent: AZD5462 Dose 4 Randomized participants of Japanese descent will receive Dose 4 of AZD5462. | Drug: AZD5462 Participants will receive AZD5462, at dose levels of 1 to 5 in part A and at 1 to 4 in part B, respectively. |
Experimental: Cohort A7: AZD5462 Dose 5 Randomized healthy participants will receive Dose 5 of AZD5462. | Drug: AZD5462 Participants will receive AZD5462, at dose levels of 1 to 5 in part A and at 1 to 4 in part B, respectively. |
Experimental: Cohort A8 Japanese descent: AZD5462 Dose 5 Randomized participants of Japanese descent will receive Dose 5 of AZD5462. | Drug: AZD5462 Participants will receive AZD5462, at dose levels of 1 to 5 in part A and at 1 to 4 in part B, respectively. |
Placebo Comparator: Part A: Placebo (Healthy Participants) Randomized healthy participants will receive Placebo matched to AZD5462. | Drug: Placebo Participants will receive Placebo matched to AZD5462. |
Placebo Comparator: Part A: Placebo (Japanese descent participants) Randomized participants of Japanese descent will receive Placebo matched to AZD5462. | Drug: Placebo Participants will receive Placebo matched to AZD5462. |
Experimental: Cohort B1: AZD5462 Dose 1 Randomized healthy participants will receive Dose 1 of AZD5462. | Drug: AZD5462 Participants will receive AZD5462, at dose levels of 1 to 5 in part A and at 1 to 4 in part B, respectively. |
Experimental: Cohort B2: AZD5462 Dose 2 Randomized healthy participants will receive Dose 2 of AZD5462. | Drug: AZD5462 Participants will receive AZD5462, at dose levels of 1 to 5 in part A and at 1 to 4 in part B, respectively. |
Experimental: Cohort B3: AZD5462 Dose 3 Randomized healthy participants will receive Dose 3 of AZD5462. | Drug: AZD5462 Participants will receive AZD5462, at dose levels of 1 to 5 in part A and at 1 to 4 in part B, respectively. |
Experimental: Cohort B4: AZD5462 Dose 4 Randomized healthy participants will receive Dose 4 of AZD5462. | Drug: AZD5462 Participants will receive AZD5462, at dose levels of 1 to 5 in part A and at 1 to 4 in part B, respectively. |
Experimental: Cohort B5 Japanese descent: AZD5462 Dose 4 Randomized participants of Japanese descent will receive Dose 4 of AZD5462. | Drug: AZD5462 Participants will receive AZD5462, at dose levels of 1 to 5 in part A and at 1 to 4 in part B, respectively. |
Placebo Comparator: Part B: Placebo (Healthy participants) Randomized healthy participants will receive Placebo matched to AZD5462. | Drug: Placebo Participants will receive Placebo matched to AZD5462. |
Placebo Comparator: Part B: Placebo (Japanese descent participants) Randomized participants of Japanese descent will receive Placebo matched to AZD5462. | Drug: Placebo Participants will receive Placebo matched to AZD5462. |