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临床试验/jRCT2051220036
jRCT2051220036已完成不适用

Phase 1 study of EA3571 in healthy adult subjects

EA Pharma Co., Ltd0 个研究点目标入组 163 人开始时间: 2022年6月14日最近更新:

试验速览

阶段
不适用
状态
已完成
入组人数
163
主要终点
AEs

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 45age old not(—)
性别
Male

入选标准

  • A Japanese or Caucasian healthy adult aged between 20 and 44 inclusive at the time of written informed
  • A BMI meeting the following criterion at screening:
  • Japanese subjects, >= 18.5 and < 25.0 kg/m2
  • Caucasian subjects, >= 18.5 and < 30.0 kg/m2
  • Consenting in writing to participate in this clinical study on his/her own free will and able to comply with
  • the requirements in the clinical study

排除标准

  • Surgical history at screening that affects the PK of the investigational product
  • History or complication at screening or any physical finding, vital sign, ECG finding, or laboratory value at screening or baseline that raises suspicion of a clinically abnormal symptom or organ dysfunction that requires treatment
  • History of allergy to gelatin, other foods, or any drugs at screening
  • Use of prescription drugs or over-the-counter drugs within 4 weeks before the investigational product administration
  • Ongoing participation in another clinical study, or use of an investigational product or device while participating in another clinical study within 16 weeks before giving consent
  • Anyone deemed ineligible to participate in this clinical study by the investigator or sub investigator

结局指标

主要结局

AEs

Adverse Events

次要结局

未报告次要终点

研究者

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