A Phase 1 Study of EA8001 in Healthy Adult Subjects

未提供0 个研究点目标入组 27 人开始时间: 待定

适应症

试验速览

阶段: 不适用
状态: 尚未招募
入组人数: 27

研究概览研究设计入排标准研究者记录与标识符相似试验

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: Non Randomized

入排标准

年龄范围: 18age old over 至 45age old not（—）
性别: All

入选标准

•1.Male or female Japanese healthy adult subjects aged 18 years or more and less than 45 years at the time of informed consent
•2.Subjects with a BMI at screening of >=17.0 kg/m2 and <30.0 kg/m2
•3.Subjects who voluntarily provide written informed consent to participate in this study and are able to comply with the study requirements

排除标准

•Subjects with a history of clinically significant disease requiring treatment within 8 weeks before assignment to the study intervention, or a history of clinically significant infection within 4 weeks before assignment to the study intervention, or subjects who are scheduled to undergo surgery requiring general anesthesia, spinal anesthesia, or epidural anesthesia during the study
•Subjects with a history of surgical treatment at screening that may affect the evaluation of this study (e.g., resection of the liver, kidney, or gastrointestinal tract)
•Subjects who are suspected of having clinically abnormal symptoms requiring treatment or organ dysfunction on the basis of medical history/concomitant diseases, physical findings, vital signs, standard 12-lead electrocardiogram, or clinical laboratory test values at screening or eligibility assessment
•Subjects with a history of drug or alcohol dependence or abuse within 2 years, or with a positive urine drug screen or alcohol test
•Subjects who test positive for human immunodeficiency virus (HIV), hepatitis B surface antigen (HBsAg), hepatitis C virus (HCV) antibody, or syphilis
•Subjects who are currently participating in another clinical trial, or who participated in another clinical trial and received an investigational drug or used an investigational medical device within 16 weeks before informed consent
•Subjects who are pregnant or breastfeeding, have a positive pregnancy test, or do not agree to use the required contraception

研究者

发起方

未提供

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