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

Brief Summary

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.

Primary Outcomes

Secondary Outcomes

• Maximum observed plasma (peak) drug concentration (Cmax)(Part A: Day 1 to Day 4. and Day 10; Part B: Day 1 to Day 15 and Day 20)
• Area under the plasma concentration-curve from zero to the last quantifiable concentration (AUClast)(Part A: Day 1 to Day 4. and Day 10; Part B: Day 1 to Day 15 and Day 20)
• Area under plasma concentration-time curve from zero to infinity (AUC0-inf)(Part A: Day 1 to Day 4. and Day 10; Part B: Day 1 to Day 15 and Day 20)
• Renal clearance of drug from plasma (CLR)(Part A: Day 1 to Day 4. and Day 10; Part B: Day 1 to Day 15 and Day 20)
• PD analysis: Levels of disease-specific biomarkers(Part A: Day 1 to Day 4 and Day 10; Part B: Day -1, Day 1 to Day 4, Day 12 to Day 15 and Day 20)