A Phase I, Randomized, Placebo-Controlled, Dose-Escalation Study to Evaluate the Safety, Tolerability and Pharmacokinetics of IDX184 After Oral Administration in Healthy Subjects
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 48
- 主要终点
- Percentage of participants experiencing serious adverse events (SAEs)
研究概览
简要总结
The purpose of this study is to obtain single dose safety and pharmacokinetic (PK) data of IDX184 in humans. No formal hypotheses are to be tested in this study.
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
- Single (Participant)
入排标准
- 年龄范围
- 19 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Participants are in general good health.
- •All participants of childbearing potential must have agreed to use a consistent form of an acceptable double-barrier method of birth control
排除标准
- •Participant is pregnant or breastfeeding.
研究组 & 干预措施
IDX184 5 mg
Healthy participants will be administered a single 5 mg dose of IDX184.
干预措施: IDX184 (Drug)
IDX184 10 mg
Healthy participants will be administered a single 10 mg dose of IDX184.
干预措施: IDX184 (Drug)
IDX184 25 mg
Healthy participants will be administered a single 25 mg dose of IDX184.
干预措施: IDX184 (Drug)
IDX184 50 mg
Healthy participants will be administered a single 50 mg dose of IDX184.
干预措施: IDX184 (Drug)
IDX184 75 mg
Healthy participants will be administered a single 75 mg dose of IDX184.
干预措施: IDX184 (Drug)
IDX184 100 mg
Healthy participants will be administered a single 100 mg dose of IDX184.
干预措施: IDX184 (Drug)
Placebo
Healthy participants will be administered placebo matching IDX184.
干预措施: Placebo (Drug)
结局指标
主要结局
Percentage of participants experiencing serious adverse events (SAEs)
时间窗: Up to Day 6
Percentage of participants experiencing AEs
时间窗: Up to Day 6
Percentage of participants experiencing dose-limiting toxicity (DLTs)
时间窗: Up to Day 6
Percentage of participants experiencing grade 1-4 laboratory abnormalities
时间窗: Up to Day 6
次要结局
未报告次要终点