A Study to Investigate the Safety and Pharmacokinetics of AZD6793 in Healthy Japanese and Chinese Participants

Part of paid clinical trials in Glendale, California.

Sponsor
AstraZeneca
Study ID
NCT06368440
Phase
PHASE1
Status
Completed

Conditions

  • Healthy Participants

Eligibility Criteria

Sex
ALL
Age
18 Years - 55 Years
Healthy Volunteers
Accepted

Interventions

  • AZD6793 — DRUG
    Participants will receive AZD6793 single dose as oral suspension.
  • AZD6793 — DRUG
    Participants will receive AZD6793 multiple doses daily as oral suspension.
  • Placebo — DRUG
    Participants will receive matching doses of placebo as oral suspension.

Study Details

The main purpose of this study is to assess the safety, tolerability and pharmacokinetics (PK) of oral AZD6793 in healthy Japanese and Chinese participants.

Key Dates

Start date
May 15, 2024
Status verified
Oct 2025
Primary completion
Dec 23, 2024
Completion
Dec 23, 2024

Study Design

Enrollment
39 participants (actual)
Allocation
RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
OTHER

Arms

  • 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.
  • 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.
  • 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.
  • 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.
  • 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.

Primary Outcome Measure

Part 1 (SAD): Number of Participants with Adverse Events [ Time Frame: From Day 1 up to Follow up visit (Day 7±1) ]

Locations (1)

FacilityCityStateZIPSite coordinators
Research SiteGlendaleCalifornia91206-

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By research site
Research Site· Glendale, CA

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