JPRN-jRCT2080224789已完成1 期
Phase I Clinical Trial of EA4017: Clinical Pharmacology Study in Healthy Adult Male Subjects
适应症
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 160
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 <= 44age old（—）
- 性别
- Male
入选标准
- •Main inclusion criteria
- •- Non-smoking Japanese and Caucasian healthy adult males.
- •- Body Mass Index (BMI) at screening is below.
- •Japanese: 18.5 or more but less than 25.0 kilogram per square metre (kg/m^2)
- •Caucasian: 18.5 or more but less than 30.0 kilogram per square metre (kg/m^2)
- •- Written, informed consent to participate in the study based on the participant's own free will and able to comply with the requirements in the study.
排除标准
- •Main exclusion criteria
- •- With a surgical history at screening period that may affect the pharmacokinetics of the investigational product.
- •- Suspicion of having a clinically abnormal symptom or an organ impairment that requires treatments based on the history/complications at screening period or physical findings, vital signs, electrocardiogram findings, or laboratory values at screening or baseline period.
- •- A history of drug allergy at screening period.
- •- Judged by the investigator or subinvestigator to be inappropriate for the participation in this study.
研究者
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