NCT06122714

A Study to Assess the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of AZD4144 Following Single and Multiple Ascending Doses Via Oral Administration to Healthy Participants

A Phase I Randomised, Single-blind, Placebo-controlled, and Sequential Group Study to Assess the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of AZD4144 Following Single and Multiple Ascending Doses Via Oral Administration to Healthy Participants

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 95 (actual)
• Sponsor: AstraZeneca · Industry
• Sex: All
• Age: 18 Years – 55 Years
• Healthy volunteers: Accepted

Summary

This study will evaluate the safety, tolerability, pharmacokinetics (PK), and pharmacodynamics (PD) of single and multiple ascending doses of AZD4144 administered orally in healthy participants.

Detailed description

This is a Phase I, first time-in human (FTiH), randomised, single-blind, placebo-controlled, single ascending dose (SAD) and multiple ascending dose (MAD) sequential group study in healthy participants. Part A consists of 3 parts: Part A1 (healthy participants) Part A2 (healthy Japanese participants) and Part A3 (healthy Chinese participants) Part B consists of 2 parts: Part B1 (healthy participants) Part B2 (healthy Japanese participants) Both Part A and Part B of the study will comprise of a screening period of maximum 28 days. The treatment period would last from Day -1 to Day 4 in Part A and from Day -1 to Day 15 in Part B of the study. A follow up visit will be performed on Day 10 + 3 days for Part A and on Day 20 + 3 days for Part B. Each participant will participate for about 6 weeks in Part A of the study and for about 7 weeks in Part B of the study.

Conditions

• Healthy Participants

Interventions

Type	Name	Description
DRUG	AZD4144 Part A	Part A: Participants will be administered a single oral dose on Day 1.
DRUG	AZD4144 Part B	Part B: Participants will be administered a single dose on Day 1, and repeated dosing will commence from Day 4 until Day 11 (inclusive) and a single dose on Day 12.
DRUG	Placebo Part A	Part A: Participants will be administered a single oral dose of matching placebo on Day 1.
DRUG	Placebo Part B	Part B: Participants will be administered a single dose of matching placebo on Day 1, and repeated dosing will commence from Day 4 until Day 11 (inclusive) and a single dose on Day 12.

Timeline

• Start date: 2023-11-07
• Primary completion: 2024-12-04
• Completion: 2024-12-04
• First posted: 2023-11-08
• Last updated: 2024-12-13

Locations

2 sites across 1 country: United States

Regulatory

• FDA-regulated drug study