JPRN-jRCT2031210202
已完成
1 期
A Phase 1 study of S-217622 in healthy adult participants
agata Tsutae0 个研究点目标入组 201 人2021年7月16日
适应症COVID-19
概览
- 阶段
- 1 期
- 干预措施
- 未指定
- 疾病 / 适应症
- COVID-19
- 发起方
- agata Tsutae
- 入组人数
- 201
- 状态
- 已完成
- 最后更新
- 2年前
概览
简要总结
暂无简介。
研究者
入排标准
入选标准
- •Japanese healthy adult male participants (SAD Part, DDI with dexamethasone and prednisolone Part)
- •Japanese healthy adult male, white healthy adult male or Japanese healthy adult female participants (MAD Part)
- •Japanese healthy adult male and female participants (FE Part, DDI with midazolam Part)
- •White healthy adult male and female participants (W\-MAD Part)
- •Participants must be 20 to 55 years of age inclusive, at the time of signing the informed consent form (SAD Part, MAD Part, DDI Part, FE Part, W\-MAD Part)
- •Participants must be 65 years of age or older inclusive, at the time of signing the informed consent form (Elderly Part)
排除标准
- •History of cardiovascular, respiratory, hepatic, renal, gastrointestinal, endocrinological, hematological, or neurological disorders capable of significantly altering the absorption, metabolism, or elimination of drugs; constituting a risk when taking the study intervention; or interfering with the interpretation of data
- •Positive SARS\-CoV\-2 RT\-PCR test at admission
结局指标
主要结局
未指定
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