A Dose-randomized, Double-blind, Placebo-controlled, Single- and Multiple-dose, Dose-escalation, Phase I Clinical Trial to Investigate the Safety, Tolerability, and Pharmacokinetic and Pharmacodynamic of JP-2266 in Healthy Subjects
试验速览
- 阶段
- 1 期
- 入组人数
- 80
- 试验地点
- 1
- 主要终点
- Assessment of PK parameter: Maximum plasma concentration (Cmax)
研究概览
简要总结
Phase I Clinical Trial to Investigate the Safety, Tolerability, and Pharmacokinetic and Pharmacodynamic Characteristics of JP-2266 after Oral Administration in Healthy Male Caucasian Subjects
详细描述
A Dose-randomized, Double-blind, Placebo-controlled, Single- and Multiple-dose, Dose-escalation, Phase I Clinical Trial to Investigate the Safety, Tolerability, and Pharmacokinetic and Pharmacodynamic Characteristics of JP-2266 after Oral Administration in Healthy Male Caucasian Subjects
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
- 18 Years 至 50 Years（Adult）
- 性别
- Male
- 接受健康志愿者
- 是
入选标准
- •Healthy male Caucasian subject aged 18 to 50 years inclusive
- •Body Mass Index (BMI) between 18 and 27 kg/m2 inclusive and body weight ≥ 50 kg at screening
- •Signing a written informed consent prior to selection;
排除标准
- •Any history (including family history) or presence of cardiovascular, pulmonary, gastro-intestinal, hepatic, renal, metabolic, haematological, neurologic, psychiatric, systemic or infectious disease;
研究组 & 干预措施
JP-2266
Drug: JP-2266
干预措施: JP-2266 (Drug)
JP-2266 Placebo
Drug: JP-2266 Placebo
干预措施: JP-2266 Placebo (Drug)
结局指标
主要结局
Assessment of PK parameter: Maximum plasma concentration (Cmax)
时间窗: up to 72hours of each period
Food effect cohort
The evaluation of the number of adverse events and the number and percentage of subjects
时间窗: up to Day 19
Multiple Ascending Dose
次要结局
未报告次要终点