A Phase I Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of LW402 Tablets Following Multiple Doses in Healthy Volunteers
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- 入组人数
- 36
- 试验地点
- 1
- 主要终点
- Safety and Tolerability Assessment
研究概览
简要总结
This Phase 1, double-blind (sponsor open), placebo controlled study will assess the safety, tolerability and pharmacokinetics of multiple doses of LW402 tablets in healthy volunteers.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Sequential
- 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
- •Healthy male and female subjects of non-child bearing potential as determined by medical history, physical exam and vial sign measurements
- •Body Mass Index of 18-26 kg/m2 inclusive with body weight males ≥ 50 kg, females ≥ 45 kg
排除标准
- •Clinically significant disease that requires a physician's care and/or would interfere with study evaluations
- •History of drug or alcohol abuse, consumption of alcohol within 48 hours prior to randomization, or a positive test for alcohol or drugs with a high potential for abuse prior to randomization
- •Other exclusion criteria apply
研究组 & 干预措施
Dose 300mg
LW402 300 mg, PO BID
干预措施: Experimental (Drug)
Dose 200mg
LW402 200 mg, PO BID
干预措施: Experimental (Drug)
Dose 250mg
LW402 250 mg, PO BID
干预措施: Experimental (Drug)
Placebo Dose 200mg
LW402 placebo tablets,200 mg, PO BID
干预措施: Placebo (Drug)
Placebo Dose 250mg
LW402 Placebo Tablets,250 mg, PO BID
干预措施: Placebo (Drug)
Placebo Dose 300mg
LW402 Placebo Tablets,300mg,BID
干预措施: Placebo (Drug)
结局指标
主要结局
Safety and Tolerability Assessment
时间窗: up to 9 days
Safety and Tolerability Assessment: Incidence and severity of adverse events (AEs) and serious adverse events (SAEs), along with abnormal clinical laboratory parameters, vital signs, physical examination findings, and 12-lead electrocardiogram (ECG) results.
次要结局
- Evaluate the PK characteristics(up to 9 days)