A 2-stage Phase 1 Study of Safety, Tolerability, PK, and PD of IW-1973 Tablet in Healthy Volunteers in an Open-label, Single-dose Stage, and a Randomized, Double Blind, Placebo-controlled, Multiple-ascending-dose Stage
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 54
- 试验地点
- 1
- 主要终点
- Treatment Emergent Adverse Events
研究概览
简要总结
Stage 1: To assess the safety, tolerability, pharmacokinetic (PK) profile, and pharmacodynamic (PD) effects of the IW-1973 Tablet administered orally to healthy volunteers, in fed and fasted states, in a single-dose crossover study.
Stage 2: To assess the safety, tolerability, PK profile, and PD effects of a range of doses of IW-1973 Tablet administered orally to healthy subjects in a 21-day, multiple ascending-dose study with optional up-titration of dose level within cohort.
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 55 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Subject is an ambulatory male or female between 18 and 55 years old at the Screening Visit
- •Subject's body mass index score is > 18.5 and < 30.0 kg/m2 at the Screening Visit
- •Women of childbearing potential must have a negative pregnancy test and must agree to use double-barrier contraception
- •Subject is in good health and has no clinically significant findings on a physical examination
- •Other inclusion criteria per protocol
排除标准
- •History of any clinically significant medical condition
- •Other exclusion criteria per protocol
研究组 & 干预措施
IW-1973
1973 Escalating Doses
干预措施: IW-1973 (Drug)
Placebo
Matching Placebo
干预措施: Matching Placebo Tablet (Drug)
结局指标
主要结局
Treatment Emergent Adverse Events
时间窗: 42 Days
Maximum observed plasma concentration (Cmax)
时间窗: 42 Days
Serum cGMP
时间窗: 42 Days
Blood Pressure
时间窗: 42 days
Area under the plasma concentration time curve during a dosing interval (AUC)
时间窗: 42 Days
Time of maximum observed plasma concentration (Tmax)
时间窗: 42 Days
Heart rate
时间窗: 42 Days
次要结局
未报告次要终点