NCT02193217已完成1 期
A Phase 1 Study to Explore the Cardiac Pharmacodynamics of MT-1303
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
- 81
- 试验地点
- 1
- 主要终点
- Mean hourly heart rate
研究概览
简要总结
The purpose of this study is to explore the cardiac pharmacodynamics, safety and tolerability of MT-1303 in healthy subjects.
研究设计
- 研究类型
- Interventional
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 and free from clinically significant illness or disease.
- •Male and female subjects of non-childbearing potential aged 18 to 55 years.
- •Normal or non-clinically significant 12-lead ECG.
- •Holter recording with no clinically significant abnormalities.
- •Systolic blood pressure: 90 to 140 mmHg, diastolic blood pressure: 50 to 90 mmHg
排除标准
- •A History of severe adverse reaction or allergy to any medical product.
- •Clinically significant endocrine, thyroid, hepatic, respiratory, gastrointestinal, renal, cardiovascular disease, eye disorder or history of psychiatric/psychotic disorder.
- •A history of tuberculosis.
- •Have a positive HBsAg, HBcAb, HCVAb or HIV-1 and HIV-2 test.
- •Previously having received MT-1303, fingolimod, or any other sphingosine-1-phosphate receptor modulators.
- •Clinical relevant abnormal medical history, or physical findings or laboratory values.
- •Clinically significant 12-lead ECG abnormalities.
- •Clinical relevant abnormal findings in echocardiograph.
研究组 & 干预措施
MT-1303-Low
Experimental
MT-1303-Low dose
干预措施: MT-1303-Low (Drug)
MT-1303-High
Experimental
MT-1303-High dose
干预措施: MT-1303-High (Drug)
Fingolimod
Active Comparator
Fingolimod
干预措施: Fingolimod (Drug)
Placebo
Placebo Comparator
Placebo
干预措施: Placebo (Drug)
结局指标
主要结局
Mean hourly heart rate
时间窗: up to day 42
次要结局
- Plasma concentration of MT-1303 and its metabolite(up to day 28)
研究者
研究点 (1)
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