jRCT2071240076尚未招募不适用
Mass Balance Study of NS-229 in Healthy Adult Males (Phase I) (NS229-P1-03)
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 8
- 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
- Single Arm Study
- 干预模型
- Single Assignment
- 主要目的
- Other
- 盲法
- Open(masking Not Used)
入排标准
- 年龄范围
- 20age old over 至 40age old not（—）
- 性别
- Male
入选标准
- •Provided written informed consent
- •Japanese male subjects
- •Body mass index (BMI) >=18.5 and <25.0 kg/m2 at the time of screening tests and hospitalization
排除标准
- •Subjects with active systemic infections (including tuberculosis, pneumonia, pneumocystis pneumonia, sepsis, opportunistic infections)
- •Medically problematic values of activated partial thromboplastin time (APTT) or prothrombin timeinternational
- •normalized ratio (PT-INR) at screening
- •Subjects with a history of blood disease
结局指标
主要结局
-
Pharmacokinetics and safety of NS-229
次要结局
未报告次要终点
研究者
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