A Phase 1, Double-Blinded, Randomised, Placebo-Controlled, Single Ascending Dose (SAD) Study in Healthy Subjects to Evaluate the Safety, Pharmacokinetics, and Pharmacodynamics of AB801
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 32
- 试验地点
- 1
- 主要终点
- Area Under the Plasma Drug Concentration-Time Curve (AUC)
研究概览
简要总结
The primary purpose of this study is to determine the safety and tolerability of AB801, and to understand the pharmacokinetic (PK) profile of AB801 when taken as a capsule and tablet in healthy volunteers.
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
- •Healthy as determined by medical evaluation by study physician
- •Body mass index (BMI) of 18.0 to 32.0 kilogram (kg)/meter (m)^2 as measured at screening
- •Weight ≥ 50 kg at screening
- •Must agree to adhere to the protocol defined contraception requirements
排除标准
- •Do not have suitable veins for multiple venepunctures/cannulation as assessed by the study physician
- •Prolonged QT interval defined as mean Corrected QT interval by Fridericia's formula (QTcF) ≥ 450 msec for males and > 470 millisecond (msec) for females at screening and pre-dose
- •Clinically significant abnormal clinical chemistry, haematology or urinalysis as judged by the study physician
- •Received any study medicine in a clinical research study within the last 90 days
- •Taking, or have taken, any prescribed or over-the-counter drugs including gastric acid reducing agents and including CYP3A inhibitor and/or inducers
- •Note: Other protocol defined Inclusion/Exclusion criteria may apply.
研究组 & 干预措施
Cohort 1 - AB801 Dose A
Participants will receive a single dose of AB801 or placebo
干预措施: AB801 (Drug)
Cohort 1 - AB801 Dose A
Participants will receive a single dose of AB801 or placebo
干预措施: Placebo (Drug)
Cohort 2 - AB801 Dose B
Participants will receive a single dose of AB801 or placebo
干预措施: AB801 (Drug)
Cohort 2 - AB801 Dose B
Participants will receive a single dose of AB801 or placebo
干预措施: Placebo (Drug)
Cohort 3 - AB801 Dose C
Participants will receive a single dose of AB801 or placebo
干预措施: AB801 (Drug)
Cohort 3 - AB801 Dose C
Participants will receive a single dose of AB801 or placebo
干预措施: Placebo (Drug)
Cohort 4 - AB801 Dose D
Participants will receive a single dose of AB801 or placebo
干预措施: AB801 (Drug)
Cohort 4 - AB801 Dose D
Participants will receive a single dose of AB801 or placebo
干预措施: Placebo (Drug)
结局指标
主要结局
Area Under the Plasma Drug Concentration-Time Curve (AUC)
时间窗: Predose, Up to 120 hours postdose
Maximum Concentration (Cmax) in Plasma
时间窗: Predose, Up to 120 hours postdose
Number of Participants with Adverse Events (AEs)
时间窗: Up to 30 days
Half-Life Time (t1/2)
时间窗: Predose, Up to 120 hours postdose
Time to Maximum Concentration (Tmax) in Plasma
时间窗: Predose, Up to 120 hours postdose
次要结局
- Change from Baseline in Holter Electrocardiogram Monitoring Scale(Predose up to 25 hours postdose)