临床试验/NCT06122714

NCT06122714已完成1 期

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

AstraZeneca1 个研究点分布在 1 个国家目标入组 95 人开始时间: 2023年11月7日最近更新: 2024年12月13日

适应症

干预措施

试验速览

阶段: 1 期
状态: 已完成
发起方: AstraZeneca
入组人数: 95
试验地点: 1
主要终点: Number of participants with adverse events (AEs)

研究概览研究设计入排标准研究组 & 干预措施结局指标研究者研究点记录与标识符相似试验

研究概览

简要总结

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.

详细描述

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)

研究设计

研究类型: Interventional
分配方式: Randomized
干预模型: Sequential
主要目的: Treatment
盲法: Double (Participant, Investigator)

入排标准

年龄范围: 18 Years 至 55 Years（Adult）
性别: All
接受健康志愿者: 是

入选标准

未提供

排除标准

未提供

研究组 & 干预措施

Part A2 (healthy Japanese participants) Cohort 2

Experimental

Participants will receive one single ascending dose of AZD4144.

干预措施: AZD4144 Part A (Drug)

Part A2 (healthy Japanese participants) placebo

Placebo Comparator

Participants will receive matching placebo.

干预措施: Placebo Part A (Drug)

Part A1 (healthy participants) Cohort 1

Experimental

Participants will receive one single ascending dose of AZD4144.

干预措施: AZD4144 Part A (Drug)

Part A1 (healthy participants) Cohort 2

Experimental

Participants will receive one single ascending dose of AZD4144.

干预措施: AZD4144 Part A (Drug)

Part A1 (healthy participants) Cohort 3

Experimental

Participants will receive one single ascending dose of AZD4144.

干预措施: AZD4144 Part A (Drug)

Part A1 (healthy participants) Cohort 4

Experimental

Participants will receive one single ascending dose of AZD4144.

干预措施: AZD4144 Part A (Drug)

Part A1 (healthy participants) Cohort 5

Experimental

Participants will receive one single ascending dose of AZD4144.

干预措施: AZD4144 Part A (Drug)

Part A1 (healthy participants) Cohort 6

Experimental

Participants will receive one single ascending dose of AZD4144.

干预措施: AZD4144 Part A (Drug)

Part A1 (healthy participants) placebo

Placebo Comparator

Participants will receive matching Placebo.

干预措施: Placebo Part A (Drug)

Part A2 (healthy Japanese participants) Cohort 1

Experimental

Participants will receive one single ascending dose of AZD4144.

干预措施: AZD4144 Part A (Drug)

Part A3 (healthy Chinese participants) Cohort 1

Experimental

Participants will receive one single ascending dose of AZD4144.

干预措施: AZD4144 Part A (Drug)

Part A3 (healthy Chinese participants) placebo

Placebo Comparator

Participants will receive matching placebo.

干预措施: Placebo Part A (Drug)

Part B1 (healthy participants) Cohort 1

Experimental

Participants will receive one multiple ascending dose of AZD4144.

干预措施: AZD4144 Part B (Drug)

Part B1 (healthy participants) Cohort 2

Experimental

Participants will receive one multiple ascending dose of AZD4144.

干预措施: AZD4144 Part B (Drug)

Part B1 (healthy participants) Cohort 3

Experimental

Participants will receive one multiple ascending dose of AZD4144.

干预措施: AZD4144 Part B (Drug)

Part B1 (healthy participants) placebo

Placebo Comparator

Participants will receive matching placebo.

干预措施: Placebo Part B (Drug)

Part B2 (healthy Japanese participants) Cohort 1

Experimental

Participants will receive one multiple ascending dose of AZD4144.

干预措施: AZD4144 Part B (Drug)

Part B2 (healthy Japanese participants) placebo

Placebo Comparator

Participants will receive matching placebo.

干预措施: Placebo Part B (Drug)

结局指标

主要结局

Number of participants with adverse events (AEs)

时间窗: Part A: From screening (Day -28 to Day -2) to Day 10; Part B: From screening (Day -28 to Day-2) to Day 20

To assess the safety and tolerability of AZD4144 following oral administration of single and multiple ascending doses (Part A and Part B)

次要结局

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)

研究者

发起方

AstraZeneca

申办方类型

Industry

责任方

Sponsor

研究点 (1)

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