jRCT2071240056招募中不适用
ONO-4915-01:ONO-4915 Phase I study A Phase I randomized, single-blind, parallel-group study in Japanese healthy adult males to evaluate the safety, tolerability, pharmacokinetics, pharmacodynamics, and immunogenicity of ONO-4915 given as a single continuous intravenous dose, a single subcutaneous dose, and repeated subcutaneous doses
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 160
- 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
- Treatment Purpose
- 盲法
- Single Blind
入排标准
- 年龄范围
- 18age old over 至 45age old under（—）
- 性别
- Male
入选标准
- •Japanese healthy adult male subjects
- •Age at the time of informed consent: 18 to 45
- •BMI (at screening): 18.5 kg/m2 to less than 25.0 kg/m2
排除标准
- •Subjects who are on a treatment for or with a history of respiratory, cardiovascular, psychiatric, neurologic, gastrointestinal, immunologic, hepatic, renal, hematopoietic or endocrine and/or other disease.
- •Subjects with current or with a history of severe allergy to drugs or foods
- •Subjects with current or with a history of drug or alcohol abuse
结局指标
主要结局
-
Safety, Pharmacokinetics
次要结局
未报告次要终点
研究者
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