A Phase 1, Randomized, Partial-Blind, Placebo-controlled, Sequential Dose Group, Ascending, Multiple Dose Study of the Safety, Tolerability and Pharmacokinetics, With Food Effect, of CMX157 in Healthy Subjects
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- 入组人数
- 50
- 主要终点
- Evaluation of the safety and tolerability of multiple oral doses of CMX157 at increasing dose levels.
研究概览
简要总结
This is a phase 1 study to evaluate the safety and tolerability of multiple oral doses of CMX157 at increasing dose levels.
详细描述
This is a phase 1 study to evaluate the safety and tolerability of multiple oral doses of CMX157 at increasing dose levels, in a fasted state and a fed 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
- Single (Participant)
入排标准
- 年龄范围
- 18 Years 至 55 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Capable of giving written informed consent.
- •Capable of completing study requirements.
排除标准
- •Positive result for HIV, HBV, or HCV.
- •History or medical condition which could impact patient safety.
- •Current or past abuse of alcohol or illicit drugs.
- •Participation in another clinical trial within the past 30 days.
研究组 & 干预措施
Group D
CMX157, tablet, 50 mg, QD, 14 days versus CMX157, placebo tablet, 50 mg, QD, 14 days
干预措施: CMX157 (Drug)
Group A
CMX157, tablet, 5 mg, QD, 14 days versus CMX157 placebo, 5 mg, tablet, QD, 14 days
干预措施: CMX157 (Drug)
Group A
CMX157, tablet, 5 mg, QD, 14 days versus CMX157 placebo, 5 mg, tablet, QD, 14 days
干预措施: placebo (Drug)
Group B
CMX157, tablet, 10 mg, QD, 14 days versus CMX157, placebo tablet, 10 mg, QD, 14 days
干预措施: CMX157 (Drug)
Group B
CMX157, tablet, 10 mg, QD, 14 days versus CMX157, placebo tablet, 10 mg, QD, 14 days
干预措施: placebo (Drug)
Group C
CMX157, tablet, 25 mg, QD, 14 days versus placebo CMX157, placebo tablet, 25 mg, QD, 14 days
干预措施: CMX157 (Drug)
Group C
CMX157, tablet, 25 mg, QD, 14 days versus placebo CMX157, placebo tablet, 25 mg, QD, 14 days
干预措施: placebo (Drug)
Group D
CMX157, tablet, 50 mg, QD, 14 days versus CMX157, placebo tablet, 50 mg, QD, 14 days
干预措施: placebo (Drug)
Group E
CMX157, tablet, 100 mg, QD, 14 days versus CMX157, placebo tablet, 100 mg, QD, 14 days
干预措施: CMX157 (Drug)
Group E
CMX157, tablet, 100 mg, QD, 14 days versus CMX157, placebo tablet, 100 mg, QD, 14 days
干预措施: placebo (Drug)
结局指标
主要结局
Evaluation of the safety and tolerability of multiple oral doses of CMX157 at increasing dose levels.
时间窗: 28 days
Capture adverse events, physical examinations, ECGs and clinical laboratory panels.
次要结局
- Evaluation of the pharmacokinetics of multiple doses of oral CMX157 in a fasted state.(28 days)
- Evaluation of the pharmacokinetics of multiple doses of oral CMX157 in a fed state.(28 days)