A Randomized, Double-blind, Placebo-controlled, Single Ascending Dose, Phase 1 Clinical Trial to Evaluate the Safety/Tolerability and PK Characteristics, and to Explore Food Effect and Ethnic Difference of JW2286 in Healthy Volunteers
试验速览
- 阶段
- 1 期
- 状态
- 招募中
- 发起方
- 入组人数
- 72
- 试验地点
- 1
- 主要终点
- Area under the plasma drug concentration-time curve from 0 to last (AUClast) of JW2286
研究概览
简要总结
This clinical trial is a randomized, double-blind, placebo-controlled, single ascending dose, phase 1 clinical trial to evaluate the safety/tolerability and pharmacokinetic characteristics, and to explore food effect and ethnic difference of JW2286 after oral administration in healthy adults.
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)
入排标准
- 年龄范围
- 19 Years 至 50 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Healthy Korean or Caucasian volunteers
排除标准
- •Individuals with a clinically significant disease or history
- •Individuals with a history of a gastrointestinal disorder or surgery
- •In the case of all female individuals with childbearing potential, except for those who are surgically sterile
研究组 & 干预措施
Test group (JW2286)
Ethnicity: Korean or Caucasian
干预措施: JW2286 (Drug)
Placebo group (Placebo of JW2286)
Ethnicity: Korean or Caucasian
干预措施: Placebo of JW2286 (Drug)
结局指标
主要结局
Area under the plasma drug concentration-time curve from 0 to last (AUClast) of JW2286
时间窗: 0 to 168 hours
Pharmacokinetic Characteristics Evaluation
Area under the plasma drug concentration-time curve from 0 to infinity (AUCinf) of JW2286
时间窗: 0 to 168 hours
Pharmacokinetic Characteristics Evaluation
The maximum or peak concentration between zero and dosing interval (Cmax) of JW2286
时间窗: 0 to 168 hours
Pharmacokinetic Characteristics Evaluation
Time of Maximum Concentration (Tmax) of JW2286
时间窗: 0 to 168 hours
Pharmacokinetic Characteristics Evaluation
次要结局
未报告次要终点