A Phase 1 Single Dose Study of E6011 in Japanese Healthy Adult Male Subjects
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 64
- 主要终点
- Number of Participants with Adverse Events
研究概览
简要总结
To evaluate the safety, tolerability, pharmacokinetics and pharmacodynamics of a single ascending dose (SAD) administration of E6011 in Japanese healthy volunteers.
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
- 20 Years 至 44 Years（Adult）
- 性别
- Male
- 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
E6011
干预措施: E6011 (Drug)
E6011 Matching Placebo
干预措施: E6011 Matching Placebo (Drug)
结局指标
主要结局
Number of Participants with Adverse Events
时间窗: Up to Week 24
An Adverse Event (AE) is any untoward medical occurrence in a participant administered an investigational product. An AE does not necessarily have a causal relationship with the medicinal product. The investigator or sub-investigator reviews all laboratory findings and determines if they constitute an AE. In-patient observation assessments will be performed during 1 week post-dose, followed by the out-patient observation assessments in groups: 0.0006, 0.006, 0.04, 0.2 mg/kg up to the end of Week 8 and in groups: 1, 3, 6, 10 kg/mg) up to the end of Week 24.
次要结局
- Maximum Observed Plasma Concentration (Cmax)(Up to 24 Weeks post-dose)
- Area Under the Curve From Time Zero to Extrapolated Infinite Time [AUC (0 - infinity)](Up to 24 Weeks post-dose)
- Plasma Decay Half-Life (t1/2)(Up to 24 Weeks post-dose)
- Pharmacokinetic Parameter: Volume of Distribution (Vd)(Up to 24 Weeks post-dose)
- Pharmacokinetic Parameter: Clearance (CL)(Up to 24 Weeks post-dose)
- Time to Reach Maximum Observed Plasma Concentration (Tmax)(Up to 24 Weeks post-dose)
- Area Under the Curve From Time Zero to Last Quantifiable Concentration [AUC (0-t)](Up to 24 Weeks post-dose)