JPRN-UMIN000005922已完成未知
Phase 1 clinical study of multiple intravenous doses of TRM-1106 in healthy Japanese adult men - TRM-1106 multiple doses study
适应症
试验速览
- 阶段
- 未知
- 状态
- 已完成
- 入组人数
- 20
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
- 20years-old 至 ot applicable（—）
- 性别
- Male
入选标准
- 未提供
排除标准
- •1) Subject who has been tested positive in a urine drug test or has a history of drug abuse. 2) Subject who has been tested positive for HBs antigen, HCV antibody or HIV antibody, or who has a positive serological test for syphilis. 3) Subject who has a history of hypersensitivity or allergy to the study drug (active component and additives) 4) Subject who currently has or has a history of peptic ulcer; or subject who currently has or has a history of asthma. 5) Subject with clinically significant disease related to the heart, liver, kidneys, respiratory system, gastrointestinal system, endocrine system, immune system, skin, blood, or psychiatric/nervous system. 6) Subject who has liver function test values (T-Bil/D-Bil, ALT (GPT), AST (GOT), gamma-GTP and ALP) that exceed the facility's upper limit. However, if the investigator deems that the reason for exceeding the limit is not due to the liver, the subject may be enrolled. 7) Subject who currently has or have a history of clinically significant bleeding or bleeding tendency. 8) Subject who has taken other medication or supplements within 1 week prior to study drug administration. 9) Subject who need to take other medication concurrently while participating in this study. 10) Subject who smoked tobacco within 1 month prior to study drug administration. 11) Subject who habitually consume a large amount of alcohol (ingestion of >=60 g per day as pure alcohol), or have ingested alcohol within 3 days prior to study drug administration. 12) Subject who has ingested food products containing St. John's wort within 2 weeks prior to study drug administration. 13) Subjects who has ingested grapefruit or processed grapefruit products within 1 week prior to study drug administration.
研究者
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