JPRN-jRCT2071200055尚未招募1 期
Safety, tolerability and pharmacokinetics of single and multiple rising doses of BI 764198 in Japanese healthy male subjects (double-blind, randomised, placebo-controlled within dose groups, parallel group design)
Ogawa Shintaro0 个研究点目标入组 44 人开始时间: 2020年11月25日最近更新:
适应症
试验速览
- 阶段
- 1 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 44
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- >= 20age old 至 <= 45age old(—)
- 性别
- Male
入选标准
- •Healthy male subjects, age of 20 to 45 years (inclusive), body mass index (BMI) of 18.5 to 25.0 kg/m2 (inclusive)
排除标准
- •1.Any finding in the medical examination (including BP, PR or ECG) deviating from normal and assessed as clinically relevant by the investigator
- •2.Repeated measurement of systolic blood pressure outside the range of 90 to 140 mmHg, diastolic blood pressure outside the range of 50 to 90 mmHg, or pulse rate outside the range of 50 to 90 bpm
- •3.Any laboratory value outside the reference range that the investigator considers to be of clinical relevance
- •4.Any evidence of a concomitant disease assessed as clinically relevant by the investigator
研究者
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