Study identifier:D7860C00003
ClinicalTrials.gov identifier:NCT06368440
EudraCT identifier:N/A
CTIS identifier:N/A
A Single-blind, Randomized, Placebo-controlled Study to Investigate the Safety, Tolerability and Pharmacokinetics of an oral suspension of AZD6793 Following Single and Multiple Doses in Japanese and Chinese Healthy Participants
Healthy Participants
Phase 1
Yes
AZD6793, Placebo
All
39
Interventional
18 Years - 55 Years
Allocation: Randomized
Endpoint Classification: -
Intervention Model: Sequential Assignment
Masking: -
Primary Purpose: Other
Verified 01 Dec 2024 by AstraZeneca
AstraZeneca
-
The main purpose of this study is to assess the safety, tolerability and pharmacokinetics (PK) of oral AZD6793 in healthy Japanese and Chinese participants.
This study will be conducted to assess the safety, tolerability, and PK of oral AZD6793 suspension following single (Part 1) and multiple (Part 2) administrations in healthy Japanese and Chinese participants performed at a single Clinical Unit. Part 1 of the study will comprise: - A Screening Period of maximum 28 days (Day -29 to Day -2). - A Treatment Period during which participants will be resident at the Clinical Unit from Day -1 until at least 72 hours after study intervention administration. - A Follow-up Visit within 6 ± 1 days after the study intervention administration. Part 2 of the study will comprise: - A Screening Period of maximum 28 days (Day -29 to Day -2). - A Treatment Period during which participants will be resident at the Clinical Unit from Day -1 (the day before first study intervention administration [Day 1]) until Day 10. - A Follow-up Visit within 6 ± 1 days after the last study intervention administration. Participants will be randomized to receive AZD6793 and placebo in both Part 1 and Part 2. Participants who enrolled in Part 1 will be excluded from participation in Part 2 of the study.
Location
Location
Glendale, CA, United States, 91206
Arms | Assigned Interventions |
---|---|
Experimental: Part 1: Cohort 1 AZD6793 6 Healthy Japanese participants will receive single dose of AZD6793 dose 1 and 2 healthy Japanese participants will receive matching placebo to AZD6793 as oral suspension on Day 1. | Drug: AZD6793 Participants will receive AZD6793 single dose as oral suspension. Drug: Placebo Participants will receive matching doses of placebo as oral suspension. |
Experimental: Part 1: Cohort 2 AZD6793 6 Healthy Japanese participants will receive single dose of AZD6793 dose 2 and 2 healthy Japanese participants will receive matching placebo to AZD6793 as oral suspension on Day 1. | Drug: AZD6793 Participants will receive AZD6793 single dose as oral suspension. Drug: Placebo Participants will receive matching doses of placebo as oral suspension. |
Experimental: Part 1: Cohort 3 AZD6793 6 Healthy Chinese participants will receive single dose of AZD6793 dose 1 and 2 healthy Chinese participants will receive matching placebo to AZD6793 as oral suspension on Day 1. | Drug: AZD6793 Participants will receive AZD6793 single dose as oral suspension. Drug: Placebo Participants will receive matching doses of placebo as oral suspension. |
Experimental: Part 2: Cohort 1 AZD6793 6 Japanese participants will receive single dose of AZD6793 and 2 participants will receive matching placebo on Day 1. After a washout of at least 48 hours, participants will receive AZD6793 or placebo once daily from Day 3 to Day 8. | Drug: AZD6793 Participants will receive AZD6793 multiple doses daily as oral suspension. Drug: Placebo Participants will receive matching doses of placebo as oral suspension. |
Experimental: Part 2: Cohort 2 AZD6793 6 Chinese participants will receive single dose of AZD6793 and 2 participants will receive matching placebo on Day 1. After a washout of at least 48 hours, participants will receive AZD6793 or placebo once daily from Day 3 to Day 8. | Drug: AZD6793 Participants will receive AZD6793 multiple doses daily as oral suspension. Drug: Placebo Participants will receive matching doses of placebo as oral suspension. |
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