JPRN-jRCT2071220036已完成1 期
A PHASE I, RANDOMIZED, DOUBLE-BLIND ,PLACEBO-CONTROLLED, DOSE ASCENDING, SINGLE DOSE STUDY TO EVALUATE SAFETY, TOLERABILITY, PHARMACOKINETICS, PHARMACODYNAMICS, AND IMMUNOGENICITY OF RAY121 IN HEALTHY VOLUNTEERS
Kai Megumi0 个研究点目标入组 40 人开始时间: 2022年8月4日最近更新:
适应症
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- 入组人数
- 40
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 <= 44age old（—）
- 性别
- All
入选标准
- •- Able to comply with the study protocol, in the investigators judgment
- •- BMI at screening: (Body weight [kg]/height [m]2) =>18.5 to <25.0
- •- Absence of evidence of any active or chronic disease following a detailed medical and surgical history and complete physical examination, vital signs, 12-lead ECG, and laboratory tests
排除标准
- •- Clinically significant ECG abnormalities at screening
- •- known congenital arrhythmiarespiratory, circulatory, endocrine, hematological, gastrointestinal, immune, psychological/nervous system, renal, hepatic, or allergic disorder
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