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

Study identifier:D6960C00001

ClinicalTrials.gov identifier:N/A

EudraCT identifier:N/A

CTIS identifier:N/A

Will Be Recruiting

Official Title

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

Medical condition

Healthy Participants

Phase

Phase 1

Healthy volunteers

Yes

Study drug

AZD8965

Sex

All

Estimated Enrollment

163

Study type

Interventional

Age

18 Years - 55 Years

Date

Study Start Date: 05 Aug 2024
Estimated Primary Completion Date: 30 May 2025
Estimated Study Completion Date: 25 Aug 2025

Study design

Allocation: Randomized
Endpoint Classification: -
Intervention Model: Sequential Assignment
Masking: -
Primary Purpose: Treatment

Verification:

Verified 01 Jul 2024 by AstraZeneca

Sponsors

AstraZeneca

Collaborators

-

Inclusion and exclusion criteria