jRCT2031230023已完成不适用
A phase 1 single-dose study of S-151128 in Japanese healthy adults
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 64
- 主要终点
- Laboratory tests
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized Controlled Trial
- 干预模型
- Parallel Assignment
- 主要目的
- Treatment Purpose
- 盲法
- Double Blind
入排标准
- 年龄范围
- 18age old over 至 55age old under（—）
- 性别
- All
入选标准
- •Aged 18 to 55 years, inclusive, at the time of informed consent.
- •Apparently healthy in the opinion of the investigator at screening and on admission.
- •Having Japanese parents.
排除标准
- •Systolic blood pressure at rest falling outside the range of 90 to 140 mmHg or diastolic blood pressure falling outside the range of 50 to 90 mmHg, or pulse rate falling outside the range of 50 to 90 bpm at screening or admission and are considered ineligible for this study by the investigator.
- •Current or a history of syncope of unknown cause, sick sinus syndrome, second or third degree atrioventricular block, myocardial infarction, pulmonary congestion, arrhythmia, angina pectoris, QT interval prolonged, or conduction abnormality.
- •Current or a history of risk factors for Torsade de Pointes (eg, cardiac failure, cardiomyopathy, hypokalemia, family history of long QT syndrome, Brugada syndrome).
结局指标
主要结局
Laboratory tests
hematology, blood chemistry, and urinalysis
Vital signs
systolic/diastolic blood pressure, body temperature, pulse rate, respiratory rate, and SpO2
12-lead ECG
HR, PR, QRS, QT, RR, QTcF
Heat perception test
warm detection threshold, heat pain threshold
次要结局
未报告次要终点
研究者
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