JPRN-UMIN000001674已完成未知
A patch test in healthy adult male subjects to investigate skin irritancy and photosensitization of KP-103 following single application, to investigate skin irritancy following repeated application for seven days(Phase I) - A patch test of KP-103 following single and repeated application(Phase I)
适应症
试验速览
- 阶段
- 未知
- 状态
- 已完成
- 入组人数
- 56
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 65years-old（—）
- 性别
- Male
入选标准
- 未提供
排除标准
- •(1) The subject with medical history of liver, renal, cardiac or hematologic disease corresponding over grade 2 of "Severity Criteria for Drug Adverse Reaction" (2) The subject with medical history of allergy to drug, or idiosyncrasy (alcohol hypersensitivity etc.) (3) The subject having been using medications regularly (4) The subject with experience of drug dependence (narcotic drug, stimulant and psychotropic drug etc), or alcoholism (5) The subject having used medications or the subject with the possibility of using medications within 1 week prior to the initiation of the investigational product administration (6) The subject having took blood drawing over 400mL within 12 weeks prior, or over 200mL within 4 weeks prior, or having took ingredient blood donation within 2 weeks prior to the initiation of the investigational product administration (7) The subject with participation in clinical trial within 16 weeks prior to the initiation of the intvesitigational product administration (8) The subject having been proved to be positive from the result of immunological tests (HBs antigen, HCV antibody, test for syphilis, HIV antigen and antibody) (9) The subject having been judged to be ineligible for the participation in this study by the investigator or sub investigator for any other reason
研究者
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