Evaluation of Safety, Tolerability and Pharmacokinetic Characteristics of Multiple Ascending Doses of CG400549 in Healthy Volunteers
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- 入组人数
- 32
- 试验地点
- 1
- 主要终点
- Number of participants with adverse events
研究概览
简要总结
The purpose of this study is to investigate the safety and tolerability of 3 multiple and escalating dose regimens of CG400549 administered orally in healthy volunteers.
详细描述
This is a Phase 1, 3 cohorts study consisting of a randomised, double-blind, and placebo-controlled design.
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
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 18 Years 至 55 Years（Adult）
- 性别
- Male
- 接受健康志愿者
- 是
入选标准
- •Age:18-55 years, inclusive
- •Body Mass Index :19-30 kg/m2, inclusive
- •Other criteria:healthy; non-smoking or smoking ≤ 10 cigarettes/day
排除标准
- •Evidence of clinically relevant pathology
- •History of bacterial or viral infection requiring treatment with antibiotics or antivirals within 1 month of study
- •Presence or history of esophageal or gastroduodenal ulceration within 1 month before screening.
研究组 & 干预措施
E1. CG400549 640mg
CG400549 640mg BID on Day 1-5 and QD on Day 6 in the fed-state
干预措施: CG400549 640mg (Drug)
E2: CG400549 320mg
CG400549 320mg QD on Day 1-5 in the fed-state.
干预措施: CG400549 320 mg (Drug)
E3: CG400549 640mg
CG400549 640mg QD on Day 1-5 in the fed-state.
干预措施: CG400549 640 mg (Drug)
E4: CG400549 960mg
CG400549 960mg QD on Day 1-5 in the fed-state.
干预措施: CG400549 960 mg (Drug)
P1 Placebo
Placebo 640mg BID on Day 1-5 and QD on Day 6 in the fed-state
干预措施: Placebo 640mg (Drug)
P2: Placebo 320mg
Placebo 320mg QD on Day 1-5 in the fed-state
干预措施: Placebo 320mg (Drug)
P3 Placebo 640mg
Placebo 640mg QD on Day 1-5 in the fed-state.
干预措施: placebo 960 mg (Drug)
P4: Placebo 960mg
Placebo 960mg QD on Day 1-5 in the fed-state.
干预措施: Placebo 640mg (Drug)
结局指标
主要结局
Number of participants with adverse events
时间窗: From Time the ICF is signed until Follow up Visit (15 days after study drug administration)
次要结局
- Pharmacokinetics-tmax(h), Cmax (ng/mL), Auc (0-24), T1/2(h)(Day1 and Day5)