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临床试验/jRCT2031220505
jRCT2031220505已完成不适用

A Phase 1, Randomized, Double-Blind, Placebo-Controlled Single and Multiple Dose Escalating Study of TAS3731 in Healthy Adults

Taiho Pharmaceutical Co., Ltd.0 个研究点目标入组 250 人开始时间: 待定最近更新:

试验速览

阶段
不适用
状态
已完成
入组人数
250

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 40age old not(—)
性别
Male

入选标准

  • (1)Healthy adult male subjects who provided written informed consent to participate in the study
  • (2)Aged 18 years or older and younger than 40 years at the time of informed consent
  • (3)Body weight of 50 kg or more at screening:
  • (4)Body mass index of 18.5 or more and less than 25.0(Japanese) or less than 30.0 kg/m2 (Caucasian)
  • (5)Capable of oral intake

排除标准

  • (1)Complications or history of diseases that may affect absorption, distribution, metabolism, or excretion of the investigational drug, such as hepatic/biliary tract disease, renal/urologic disease, or gastrointestinal disease. The stomach or small intestine has been resected.
  • (2)The 12-lead electrocardiogram at the time of the screening test was judged by the investigator to be inadequate for this study.
  • (3)Had any concurrent disease (including symptoms and signs; however, diseases that do not affect evaluations in the study such as asymptomatic pollinosis and wart are excluded)
  • (4)The patient has the following complications or a history of the following.
  • a.Had current or previous drug abuse (including use of illicit drugs) or alcoholism
  • b.Had current or previous hypersensitivity or allergy to drugs
  • (5)Suspected COVID-19 disease.

研究者

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