jRCT2031210091已完成不适用
A Phase I Single Ascending Dose Study of RO7126209 in Healthy Japanese Subjects
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 32
- 主要终点
- -
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
- 20age old over 至 40age old under(—)
- 性别
- Male
入选标准
- •Written informed consent.
- •Healthy Japanese man who is 20 to 40 years of age at the time of informed consent.
- •Individuals who are judged to be healthy based on their medical, history surgical history, or physical examination.
- •Body mass index (weight [kg]/[height [m]2) of 18.5 to 25.0 kg/m2 at screening.
- •Individuals who have agreed to abstinence or to use contraception methods and to refrain from sperm donation during the study treatment period and for a certain period after administration of the investigational drug.
排除标准
- •Individuals with cardiovascular, renal, hepatic, gastrointestinal, immunological, neurological, endocrine, metabolic, cerebrovascular, or bronchopulmonary diseases and individuals with a history of these diseases and disorder kidney, liver, or cardiorespiratory function.
- •Individuals affected by hypersensitivity to biological products or excipients in pharmaceutical products.
- •Subjects who participated in any clinical trial within 4 months before administration of the investigational product and who received the investigational product (including placebo).
- •Individuals who have received or have taken prescription drugs within 1 month before administration of the investigational product.
结局指标
主要结局
-
safety Observation
次要结局
未报告次要终点
研究者
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