JPRN-jRCT2080221894未知1 期
CS-4771 Phase 1 study - A randomized, double-blind, placebo-controlled, continuous IV infusion for 96 hours, ascending dose study to assess the safety, pharmacokinetics and pharmacodynamics of CS-4771 in Japanese healthy subjects
DAIICHISANKYO Co.,Ltd.0 个研究点目标入组 24 人开始时间: 2012年8月24日最近更新:
适应症
试验速览
- 阶段
- 1 期
- 发起方
- 入组人数
- 24
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 <= 45age old（—）
- 性别
- Male
入选标准
- •male Japanese
- •- between the age of 20 and 45
- •- between the BMI of 18.5 and 25.0
排除标准
- •- A history of serious diseases caused by disorders of the central nervous system, circulatory system, respiratory system, blood/hematopoietic system, gastrointestinal system, hepatic and renal function, thyroid function, pituitary gland function, adrenal function, etc., and the judgment of the investigator or subinvestigator that participation in the clinical study could pose a risk to the subject's safety
- •- MetHB level of 2% or greater, or MetHB value of 0.24 g/dL or greater
- •- Hypersensitivity to methylene blue or Toll-like receptor 4 (TLR4) inhibitors
- •- Inappropriateness for inclusion into the study as judged by the investigator or subinvestigator (for example, subjects who may have difficulty in visiting the study center or ensuring compliance)
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