NCT06502379

A Single and Multiple Ascending Dose Study to Investigate the Safety, Tolerability, and Pharmacokinetics of AZD8965 in Healthy Participants (Including Japanese and Chinese Participants) and an Open-label Cohort to Assess the Effect of Food on the Pharmacokinetics of AZD8965 in Healthy Participants

A Phase I Randomized, Single-blind, Placebo-controlled Study to Assess the Safety, Tolerability, and Pharmacokinetics of AZD8965 Following Single and Multiple Ascending Dose Administration to Healthy Participants (Including Japanese and Chinese Participants) and an Open-label Cohort to Assess the Effect of Food on the Pharmacokinetics of AZD8965 in Healthy Participants

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 147 (actual)
• Sponsor: AstraZeneca · Industry
• Sex: All
• Age: 18 Years – 55 Years
• Healthy volunteers: Accepted

Summary

The purpose of this study is to assess the safety, tolerability, and pharmacokinetics (PK) of AZD8965 via single and multiple ascending doses in healthy participants (including Japanese and Chinese participants), and to assess the effect of food on the safety, tolerability, and PK of orally administered AZD8965.

Detailed description

This is a first in human single and multiple ascending dose study. The study consists of 4 parts: Part 1 (single ascending dose \[SAD\]), Part 2 (multiple ascending dose \[MAD\]), Part 3A (Japanese and Chinese SAD), Part 3B (Japanese and Chinese combined SAD and MAD), and Part 4 (Food Effect). Each study part includes a 28-day screening period and a residential period during which participants will be resident at the Clinical Unit from the day before study intervention administration (Day -1) until at least 48-72 hours after the study intervention administration.

Conditions

• Healthy Participants

Interventions

Type	Name	Description
DRUG	AZD8965	AZD8965 will be administered orally.
OTHER	Placebo	Placebo will be administered orally.

Timeline

• Start date: 2024-08-02
• Primary completion: 2025-06-01
• Completion: 2025-11-15
• First posted: 2024-07-16
• Last updated: 2025-12-11

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study