A Phase I Randomized Single-blind Placebo-controlled Study to Assess the Safety, Tolerability, and Pharmacokinetics of AZD7503 Following Multiple Ascending Dose Administration to Patients With Suspected Non-cirrhotic Non-alcoholic Steatohepatitis (NASH)
试验速览
- 阶段
- 1 期
- 状态
- 终止
- 发起方
- AstraZeneca
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- Number of subjects with adverse events (AEs)
研究概览
简要总结
The purpose of this study is to measure the safety, tolerability, and PK (measurement of drug activity in the body over time) of AZD7503 injected subcutaneously, and compared to placebo, in participants with suspected NASH, a type of liver disease.
详细描述
This is a Phase I, randomised, single-blind (in which the study centre staff including the Principal Investigator, remain blinded during the clinical conduct of a given cohort) placebo controlled, multiple ascending dose (MAD) study in male and female participants conducted at multiple centres.
Each participant is expected to be in the study for approximately 24 weeks, including a screening period of up to 4 weeks, a 12-week study intervention period, and a follow-up visit at week 18 (10 weeks following the final dose). Participants will be randomly assigned in a 3:1 ratio to receive AZD7503 or placebo. Study intervention will be administered via subcutaneous injection.
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
- Triple (Participant, Care Provider, Investigator)
盲法说明
This is a single-blind, randomised, placebo-controlled, MAD study with up to 3 study intervention cohorts that are participant- and investigator-blinded.
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- 未提供
排除标准
- 未提供
研究组 & 干预措施
Cohort 1
Dose A cohort: 20 participants; n=15 on AZD7503 dose A, n=5 on Placebo
干预措施: AZD7503 (Drug)
Cohort 2
Dose B cohort: 20 participants; n=15 on AZD7503 dose B, n=5 on Placebo.
干预措施: AZD7503 (Drug)
Cohort 3
Dose C cohort: 20 participants n=15 on AZD7503 dose C, n=5 on Placebo.
干预措施: AZD7503 (Drug)
结局指标
主要结局
Number of subjects with adverse events (AEs)
时间窗: Up to and including week 19 (from pre-screening to follow-up visit)
AEs will be collected at all sites visits per SOA.
Number of subjects with serious adverse events (SAEs)
时间窗: Up to and including week 18 (from pre-screening to final visit).
SAEs will be reported and collected as they occur.
次要结局
- Maximum observed plasma drug concentration (Cmax)(Day 1 to Day 127)
- Area under the concentration-time curve from time 0 to infinity (AUCinf) for plasma PK(Day 1 to 127)
- Area under the concentration-time curve over the dosing interval (AUCtau) for plasma PK(Time frame: Day 1 to 127)
- Fraction of the dose excreted unchanged into the urine from time t1 to t2 (fe(t1-t2)) for urine PK(Day 1 and Day 57: Pre-dose and between 0-6 hours, 6-12 hours, 12-24 hours, 24-36 hours and 36-48 hours post-dose)