NCT02572349已完成1 期
A Randomized, Double-blind, Placebo-controlled, Phase 1 Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of IW-1701 Administered Orally as Single Doses to Healthy Subjects
适应症
干预措施
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 24
- 试验地点
- 1
- 主要终点
- Assessment of the safety and tolerability of IW-1701 in healthy subjects via adverse events
研究概览
简要总结
The objectives of the study are to assess the safety and tolerability of a range of single doses of IW-1701 when administered as oral capsules to healthy subjects, to determine the pharmacokinetic profile and pharmacodynamics effects of a range of single doses of IW-1701 when administered as oral capsules to healthy 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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- 未提供
排除标准
- 未提供
研究组 & 干预措施
IW-1701
Experimental
Single Dose
干预措施: IW-1701 (Drug)
Matching Placebo for IW-1701
Placebo Comparator
Single Dose
干预措施: Matching Placebo (Drug)
结局指标
主要结局
Assessment of the safety and tolerability of IW-1701 in healthy subjects via adverse events
时间窗: From baseline up to 8 days
The primary objectives of this study are to assess the safety and tolerability of single ascending dosage levels of IW-1701 versus placebo in healthy subjects.
次要结局
未报告次要终点
研究者
研究点 (1)
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