jRCT2051240123招募中不适用
A PHASE I, RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED, DOSE ASCENDING, SINGLE DOSE STUDY TO EVALUATE SAFETY, TOLERABILITY, PHARMACOKINETICS, PHARMACODYNAMICS, AND IMMUNOGENICITY OF BRY10 IN HEALTHY VOLUNTEERS
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 72
- 主要终点
- safety
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized Controlled Trial
- 干预模型
- Parallel Assignment
- 主要目的
- Treatment Purpose
- 盲法
- Double Blind
入排标准
- 年龄范围
- 18age old over 至 44age old under（—）
- 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(Asian Cohorts) or >=18.5 kg/m^2 or <30.0 kg/m^2 (non-Asian Cohorts), 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.
结局指标
主要结局
safety
- Frequency, severity and relationship of adverse events including serious adverse events (SAE) to BRY10 - Laboratory values, vital signs and ECGs
phamacokinetics
- Plasma concentrations and pharmacokinetic parameters (Cmax, Tmax, AUC, T1/2, etc.)
次要结局
未报告次要终点
研究者
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