Phase 1 study of EA3571 in healthy adult subjects

Takeuchi Yutaka0 个研究点目标入组 163 人开始时间: 2022年5月28日最近更新: 2023年11月20日

适应症

试验速览

暂无简介。

•1. A Japanese or Caucasian healthy adult aged between 20 and 44 inclusive at the time of written informed
•2. 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
•3. 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

•1. Surgical history at screening that affects the PK of the investigational product
•2. 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
•3. History of allergy to gelatin, other foods, or any drugs at screening
•4. Use of prescription drugs or over-the-counter drugs within 4 weeks before the investigational product administration
•5. 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
•6. Anyone deemed ineligible to participate in this clinical study by the investigator or sub investigator

发起方

Takeuchi Yutaka