NCT07290283

A Study to Investigate Safety, Tolerability, and Pharmacokinetics of AZD3974 in Healthy Participants

A Phase I, Randomized, Single-blind, Placebo-controlled Study to Assess the Safety, Tolerability and Pharmacokinetics of AZD3974 After Single and Multiple Ascending Dosing to Healthy Participants

• Status: Recruiting
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 176 (estimated)
• Sponsor: AstraZeneca · Industry
• Sex: All
• Age: 18 Years – 55 Years
• Healthy volunteers: Accepted

Summary

The purpose of this study is to assess the safety and tolerability of AZD3974 and characterize the pharmacokinetics (PK) of AZD3974 following oral administration to healthy participants, including participants of Japanese and Chinese descent.

Detailed description

This is a first in human, randomized, single-blind, placebo-controlled study. It consists of two parts. Part A (single ascending dose - SAD): This study part will enroll six cohorts (plus two optional additional cohorts) of healthy participants (Part A1), three cohorts (plus one optional additional cohort) of healthy Japanese participants (Part A2) and one cohort (plus one optional additional cohort) of healthy Chinese participants (Part A3). Cohort 3 of Part A1 will be extended to evaluate the effect of food intake on the PK of AZD3974. In Part A (all cohorts), participants will receive a single dose of AZD3974 or placebo. Part B (Multiple Ascending Dose - MAD): This study part will consist of four cohorts (plus two optional additional cohorts) of healthy participants (Part B1) and one cohort (plus one optional additional cohort) of healthy Japanese participants (Part B2). In all Part B cohorts, participants will receive multiple doses of AZD3974 or placebo. Both Part A and Part B will comprise of: * A Screening Period of maximum 28 days * A Dosing session during which participants will receive the study intervention at study specific time points. * Follow-up Period of 7 days post last-dose.

Conditions

• Healthy Participants

Interventions

Type	Name	Description
DRUG	AZD3974	AZD3974 will be administered as an oral solution.
OTHER	Placebo	Placebo will be administered as an oral solution.

Timeline

• Start date: 2025-12-10
• Primary completion: 2026-10-21
• Completion: 2026-10-21
• First posted: 2025-12-18
• Last updated: 2026-03-27

Locations

2 sites across 1 country: United States

Regulatory

• FDA-regulated drug study