NCT02429102已完成1 期
A Study to Investigate the Safety, Tolerability and Pharmacokinetics of MT-8554 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
- 135
- 试验地点
- 1
- 主要终点
- Safety and Tolerability as measured by vital signs
研究概览
简要总结
The purpose of this study is to investigate the safety, tolerability and pharmacokinetics of MT-8554 in healthy Caucasian subjects.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 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 male and ≥50 kg female
排除标准
- •Participation in more than three clinical studies involving administration of an Investigational Medicinal Product (IMP) in the previous year, or any study within 12 weeks.
- •Clinically significant endocrine, thyroid, hepatic, respiratory, gastro-intestinal, renal, cardiovascular 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
Single ascending dose, MT-8554 or Placebo
Experimental
干预措施: MT-8554 (Drug)
Single ascending dose, MT-8554 or Placebo
Experimental
干预措施: Placebo (Drug)
Multiple ascending dose, MT-8554 or Placebo
Experimental
干预措施: MT-8554 (Drug)
Multiple ascending dose, MT-8554 or Placebo
Experimental
干预措施: Placebo (Drug)
结局指标
主要结局
Safety and Tolerability as measured by vital signs
时间窗: up to Day14
Safety and Tolerability as measured by ECG
时间窗: up to Day14
Safety and Tolerability as measured by continuous lead II ECG monitoring
时间窗: up to Day14
Safety and Tolerability as measured by laboratory safety assessments
时间窗: up to Day14
Safety and Tolerability as measured by number of participants with adverse events
时间窗: up to Day14
Safety and Tolerability as measured by physical examination
时间窗: up to Day14
次要结局
- PK profile (Cmax, tmax, t½, AUC)(240 hours post dose)
研究者
研究点 (1)
Loading locations...
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