NCT02834442已完成1 期
A Randomised, Double Blind, Placebo Controlled Phase I Study to Investigate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of Single and Multiple Ascending Doses of MT-7117 in 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
- 144
- 试验地点
- 1
- 主要终点
- Safety and Tolerability as measured by number of participants with adverse events
研究概览
简要总结
The purpose of this study is to investigate the safety, tolerability and pharmacokinetics of MT-7117 in 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
- Double
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Healthy and free from clinically significant illness or disease
- •Male or female subjects aged 18 to 55 years or elderly male subjects aged ≥65
- •A body weight of ≥60 kg for males and ≥50 kg for females, and a body mass index ranging from 18 to 30 kg/m2
排除标准
- •Participated in more than three clinical studies involving administration of an IMP in the previous year, or any study within 12 weeks
- •Clinically significant endocrine, thyroid, hepatic, respiratory, gastro intestinal, renal, cardiovascular or skin disease, or history of any significant psychiatric/psychotic illness disorder
- •Clinically relevant abnormal medical history, physical findings or laboratory values
研究组 & 干预措施
Multiple ascending dose, MT-7117 or Placebo
Experimental
干预措施: MT-7117 (Drug)
Single ascending dose, MT-7117 or Placebo
Experimental
干预措施: MT-7117 (Drug)
Single ascending dose, MT-7117 or Placebo
Experimental
干预措施: Placebo (Drug)
Multiple ascending dose, MT-7117 or Placebo
Experimental
干预措施: Placebo (Drug)
结局指标
主要结局
Safety and Tolerability as measured by number of participants with adverse events
时间窗: up to Day56
Safety and Tolerability as measured by vital signs
时间窗: up to Day56
Safety and Tolerability as measured by ECG
时间窗: up to Day21
Safety and Tolerability as measured by physical examination
时间窗: up to Day56
Safety and Tolerability as measured by laboratory safety assessments
时间窗: up to Day21
次要结局
- Maximum plasma concentration (Cmax)(96 hours post dose)
- Area under the plasma concentration-time curve (AUC)(96 hours post dose)
- Time to maximum plasma concentration (Tmax)(96 hours post dose)
- Apparent elimination half-life in plasma(96 hours post dose)
研究者
研究点 (1)
Loading locations...
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