NCT06368440

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

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

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 39 (actual)
• Sponsor: AstraZeneca · Industry
• Sex: All
• Age: 18 Years – 55 Years
• Healthy volunteers: Accepted

Summary

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

Detailed description

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.

Conditions

• Healthy Participants

Interventions

Type	Name	Description
DRUG	AZD6793	Participants will receive AZD6793 single dose as oral suspension.
DRUG	AZD6793	Participants will receive AZD6793 multiple doses daily as oral suspension.
DRUG	Placebo	Participants will receive matching doses of placebo as oral suspension.

Timeline

• Start date: 2024-05-15
• Primary completion: 2024-12-23
• Completion: 2024-12-23
• First posted: 2024-04-16
• Last updated: 2025-10-24

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study