跳至主要内容
临床试验/jRCT2031210091
jRCT2031210091已完成不适用

A Phase I Single Ascending Dose Study of RO7126209 in Healthy Japanese Subjects

Chugai Pharmaceutical Co., Ltd.0 个研究点目标入组 32 人开始时间: 2021年7月7日最近更新:
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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