JPRN-jRCT2071230074招募中1 期
A PHASE I, RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED, SINGLE AND MULTIPLE ASCENDING DOSE STUDY TO EVALUATE SAFETY, TOLERABILITY, PHARMACOKINETICS, AND PHARMACODYNAMICS OF REVN24 IN HEALTHY MALE VOLUNTEERS
Megumi Kai0 个研究点目标入组 179 人开始时间: 2023年10月16日最近更新:
试验速览
- 阶段
- 1 期
- 状态
- 招募中
- 发起方
- 入组人数
- 179
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
- Male
入选标准
- •Signed ICF.
- •- Able to comply with the study protocol, in the investigators judgment.
- •- Have a body mass index (body weight [kg]/height [m]^2) >=18.5 kg/m^2 or <25.0 kg/m^2(Cohorts A-1 to A-9 and B-1 to B-5) or >=18.5 kg/m^2 or <30.0 kg/m^2 (Cohorts A-10 to A13), and body weight >=50 kg at screening.
- •- Have no findings indicating an active or chronic disease, based on detailed hearing of medical and surgery histories and the results of physical examination, vital sign measurements, ECG, and laboratory tests.
排除标准
- •- Clinically significant abnormal ECG at screening.
- •- Current cardiovascular, renal, hepatic, gastrointestinal, hematologic, immune, neurologic, endocrine, metabolic, or pulmonary disorder or a history of any of these disorders and impaired renal, hepatic, or cardiopulmonary function.
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