jRCT2051220036已完成不适用
Phase 1 study of EA3571 in healthy adult subjects
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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