A Single-And Multiple-Dose Study to Evaluate the Safety, Tolerability, Pharmacokinetics,Pharmacodynamics and Food Effect of WD-890 Tablets in Healthy Chinese Subjects
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- 入组人数
- 106
- 试验地点
- 1
- 主要终点
- Safety of a single oral dose of WD-890 based on number of incidence of AE, SAEs, marked abnormalities in clinical laboratory tests, vital sign measurements, ECGs, telemetry, and physical examinations
研究概览
简要总结
This is a phase I, randomised, double-blind, placebo-controlled, 3-part study to evaluate the safety, tolerability, pharmacokinetics, pharmacodynamics and food effect of WD-890 Tablets in Healthy Chinese Subjects
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Sequential
- 主要目的
- Other
- 盲法
- Double (Participant, Investigator)
盲法说明
SAD and MAD ：Double (Participant,Investigator) FE：Open Label
入排标准
- 年龄范围
- 18 Years 至 50 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
WD-890 1mg
Take a fixed dose of WD-890 tablets orally
干预措施: WD-890 (Drug)
WD-890 3mg
Take a fixed dose of WD-890 tablets orally
干预措施: WD-890 (Drug)
WD-890 6mg
Take a fixed dose of WD-890 tablets orally
干预措施: WD-890 (Drug)
WD-890 9mg
Take a fixed dose of WD-890 tablets orally
干预措施: WD-890 (Drug)
WD-890 Tablets Placebo
Take a fixed dose of WD-890 tablets Placebo orally
干预措施: WD-890 Tablets Placebo (Drug)
结局指标
主要结局
Safety of a single oral dose of WD-890 based on number of incidence of AE, SAEs, marked abnormalities in clinical laboratory tests, vital sign measurements, ECGs, telemetry, and physical examinations
时间窗: Days 1 to 5
Safety of a multiple oral dose of WD-890 based on number of incidence of AE, SAEs, marked abnormalities in clinical laboratory tests, vital sign measurements, ECGs, telemetry, and physical examinations
时间窗: Days 1 to 19
Tolerability of a multiple oral dose of WD-890 based on number of incidence of AE, SAEs, marked abnormalities in clinical laboratory tests, vital sign measurements, ECGs, telemetry, and physical examinations
时间窗: Days 1 to 19
Single Ascending Dose (SAD), Multiple Ascending Dose (MAD) and Food Effect (FE) Cohorts: Maximum Observed Plasma Concentration (Cmax) of WD-890；
时间窗: SAD: Days 1 to 4 ; MAD: Day 1, Day 6, Day 9 and Day 12; FE: Days 1 to 5, Days 8 to 12
Single Ascending Dose (SAD) and Multiple Ascending Dose (MAD) Cohorts: Apparent Plasma Elimination Half-Life (T-HALF) of WD-890
时间窗: SAD: Days 1 to 4 ; MAD: Day 1, Day 6, Day 9 and Day 12
Tolerability of a single oral dose of WD-890 based on number of incidence of AE, SAEs, marked abnormalities in clinical laboratory tests, vital sign measurements, ECGs, telemetry, and physical examinations
时间窗: Days 1 to 5
Single Ascending Dose (SAD), Multiple Ascending Dose (MAD) and Food Effect (FE) Cohorts: Area Under The Plasma Concentration-Time Curve From Time Zero to Time of Last Quantifiable Concentration (AUC(0-T)) of WD-890
时间窗: SAD: Days 1 to 4 ; MAD: Day 1, Day 6, Day 9 and Day 12 FE: Days 1 to 5, Days 8 to 12
Single Ascending Dose (SAD), Multiple Ascending Dose (MAD) and Food Effect (FE) Cohorts: Area Under The Plasma Concentration-Time Curve From Time Zero Extrapolated To Infinite Time (AUC(INF)) of WD-890
时间窗: SAD: Days 1 to 4 ; MAD: Day 1, Day 6, Day 9 and Day 12 FE: Days 1 to 5, Days 8 to 12
Single Ascending Dose (SAD) and Multiple Ascending Dose (MAD) Cohorts: Time to Maximum Observed Plasma Concentration (Tmax) of WD-890
时间窗: SAD: Days 1 to 4 ; MAD: Day 1, Day 6, Day 9 and Day 12
Single Ascending Dose (SAD) and Multiple Ascending Dose (MAD) Cohorts: Apparent Volume of Distribution (Vz/F) of WD-890
时间窗: SAD: Days 1 to 4 ; MAD: Day 1, Day 6, Day 9 and Day 12
Multiple Ascending Dose (MAD) Cohorts: Maximum Observed Plasma Concentration at Steady State (Cmax,ss) of WD-890
时间窗: Day 1, Day 6, Day 9 and Day 12
Multiple Ascending Dose (MAD) Cohorts: Time to Reach the Maximum Plasma Concentration at Steady State (Tmax,ss) of WD-890
时间窗: Day 1, Day 6, Day 9 and Day 12
Multiple Ascending Dose (MAD) Cohorts: Apparent Volume of Distribution at Steady State (Vss/F) of WD-890
时间窗: Day 1, Day 6, Day 9 and Day 12
次要结局
- Food Effect Cohorts: Time to Maximum Observed Plasma Concentration (Tmax) of WD-890(Days 1 to 5, Days 8 to 12,)
- Food Effect Cohorts: Apparent Volume of Distribution (Vz/F) of WD-890(Days 1 to 5, Days 8 to 12)
- Food Effect Cohorts: Apparent Plasma Elimination Half-Life (T-HALF) of WD-890(Days 1 to 5, Days 8 to 12,)