JPRN-jRCT2031220505招募中1 期
A Phase 1, Randomized, Double-Blind, Placebo-Controlled Single and Multiple Dose Escalating Study of TAS3731 in Healthy Adults
适应症
试验速览
- 阶段
- 1 期
- 状态
- 招募中
- 发起方
- Sato Atsushi
- 入组人数
- 250
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
- >= 18age old 至 < 40age old（—）
- 性别
- Male
入选标准
- •(1)Healthy adult male subjects who provided written informed consent to participate in the study
- •(2)Aged 18 years or older and younger than 40 years at the time of informed consent
- •(3)Body weight of 50 kg or more at screening:
- •(4)Body mass index of 18.5 or more and less than 25.0(Japanese) or less than 30.0 kg/m2 (Caucasian)
- •(5)Capable of oral intake
排除标准
- •(1)Complications or history of diseases that may affect absorption, distribution, metabolism, or excretion of the investigational drug, such as hepatic/biliary tract disease, renal/urologic disease, or gastrointestinal disease. The stomach or small intestine has been resected.
- •(2)The 12-lead electrocardiogram at the time of the screening test was judged by the investigator to be inadequate for this study.
- •(3)Had any concurrent disease (including symptoms and signs; however, diseases that do not affect evaluations in the study such as asymptomatic pollinosis and wart are excluded)
- •(4)The patient has the following complications or a history of the following.
- •a.Had current or previous drug abuse (including use of illicit drugs) or alcoholism
- •b.Had current or previous hypersensitivity or allergy to drugs
- •(5)Suspected COVID-19 disease.
研究者
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