jRCT2051210027尚未招募不适用
A Randomized, Single-Center, Double-Blind, Placebo-Controlled, Phase 1 Study to Investigate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of a Single Dose of SCO-240 in Healthy Adult Subjects
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 76
- 主要终点
- -
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
- Other
- 盲法
- Double Blind
入排标准
- 年龄范围
- 20age old over 至 45age old under（—）
- 性别
- Male
入选标准
- •Gender: Male
- •Healthy Japanese adults: The subject's parents and grand parents are Japanese
- •Healthy Caucasian adults: The subject's parents and grandparents are Caucasian
- •Age: Subjects are between 20 and 45 years, inclusive, at the time of informed consent
- •Weight at screening:
- •Healthy Japanese adults: >=50 kg, body mass index (BMI) >=18.5 kg/m2 and =<25.0 kg/m2
- •Healthy Caucasian adults >=50 kg, BMI >=18.5 kg/m2 and =<30.0 kg/m2
排除标准
- •Subjects who have a present illness such as cardiovascular disease, central nervous system disease, gastrointestinal disease, hematopoietic disease, renal failure, metabolic or endocrine disorder, serious allergy, asthma, hypoxemia, hypertension, convulsion or allergic rash.
结局指标
主要结局
-
-Safety, pharmacokinetics and pharmacodynamics
次要结局
未报告次要终点
研究者
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