A Dose Block-randomized, Double-blind, Placebo-controlled, Single and Multiple Ascending Dose, Phase I Clinical Trial to Evaluate the Safety/Tolerability and Pharmacokinetics/Pharmacodynamics of JW1601
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- 入组人数
- 102
- 试验地点
- 2
- 主要终点
- Safety and tolerability after single ascending dose administration based on laboratory values, vital signs, ECG, physical examinations and Adverse Events monitoring
研究概览
简要总结
This study is conducted to evaluate the safety/tolerability and PK/PD of JW1601 after oral administration in healthy Korean, Caucasian and Japanese adult volunteers
详细描述
This is a dose block-randomized, double-blind, placebo-controlled, single and multiple ascending dose study to assess the safety, tolerability and PK/PD profile by administering investigational product (IP) as a single dose (One time) or repeated doses (7 days, once a day) orally in a fasted state.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 19 Years 至 55 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Subjects who have voluntarily given written informed consent to participate in the study and comply with all study requirements after getting detailed explanation and full understanding of the study
排除标准
- •Subjects judged by the investigators unsuitable for participating in the study based on any other reasons
研究组 & 干预措施
JW1601
tablet formulation
干预措施: Study drug (Drug)
Placebo
tablet formulation identified with JW1601
干预措施: Placebo (Drug)
结局指标
主要结局
Safety and tolerability after single ascending dose administration based on laboratory values, vital signs, ECG, physical examinations and Adverse Events monitoring
时间窗: From Day 1 through Post Study Visit (Day 8)
AE incidence and the value or the change from baseline such as vital signs, 12-lead ECG, and clinical laboratory tests will be compared by each group and placebo group.
Safety and tolerability in multiple ascending dose administration based on laboratory values, vital signs, ECG, physical examinations and Adverse Events monitoring
时间窗: From Day 1 through Post Study Visit (Day 14)
AE incidence and the value or the change from baseline such as vital signs, 12-lead ECG, and clinical laboratory tests will be compared by each group and placebo group.
次要结局
- Cmax in plasma in single ascending dose administration(Baseline(Day 1) through Day 4)
- Tmax in plasma in single ascending dose administration(Baseline(Day 1) through Day 4)
- AUClast in plasma in single ascending dose administration(Baseline(Day 1) through Day 4)
- Eosinophil shape change(%) in single ascending dose administration(Baseline(Day -1) through Day 4)
- QT/QTc changes in single ascending dose administration(Baseline(Day -1), Day 1, Day 2)
- C(max, ss) in plasma in multiple ascending dose administration(Baseline(Day 1) through Day 10)
- T(max,ss) in plasma in multiple ascending dose administration(Baseline(Day 1) through Day 10)
- AUC(τ,ss) in plasma in multiple ascending dose administration(Baseline(Day 1) through Day 10)
- Eosinophil shape change(%) in multiple ascending dose administration(Baseline(Day -1) through Day 10)
- QT/QTc changes in multiple ascending dose administration(Baseline(Day -1), Day 7, Day 8)