NCT06951880

A Study to Investigate the Safety and Pharmacokinetics of Single- and Multiple-ascending Doses of AZD4916 in Healthy Volunteers

A Phase I, Randomized, Single-blind, Placebo-controlled, 2-Part Study to Assess the Safety, Tolerability, and Pharmacokinetics of AZD4916 Following Single- and Multiple-ascending-dose Administration to Healthy Adult Volunteers (Including Japanese and Chinese Healthy Volunteers)

• Status: Not Yet Recruiting
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 178 (estimated)
• 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, pharmacokinetics (PK) of AZD4916 in healthy adult participants.

Detailed description

This is a single-blind, placebo-controlled study conducted at a single clinical unit. The study will comprise of: * Part 1: Single ascending dose (SAD) part (part 1a) and a Multiple ascending dose (MAD) part (part 1b), both in global participants. * Part 2: SAD part (part 2a) and a MAD part (part 2b) specifically for Japanese and Chinese participants only.

Conditions

• Healthy Participants

Interventions

Type	Name	Description
DRUG	AZD4916	AZD4916 will be administered as oral solution.
OTHER	Placebo	Placebo will be administered as oral solution.

Timeline

• Start date: 2025-06-27
• Primary completion: 2026-09-24
• Completion: 2026-09-24
• First posted: 2025-04-30
• Last updated: 2025-04-30

Locations

1 site across 1 country: United Kingdom

Regulatory

• FDA-regulated drug study