Phase I Clinical Trial of EA4017: Clinical Pharmacology Study in Healthy Adult Male Subjects

EA Pharma Co., Ltd.1 个研究点目标入组 160 人开始时间: 待定最近更新: 2021年5月7日

试验速览

暂无简介。

研究类型: Interventional
干预模型: Part 1 (Japanese) and 2 (Caucasian) are designed as a single-dose, placebo-controlled, randomized, asdending dose, double-blind studies. Part 3 (Japanese) and 4 (Caucasian) are designed as a open label, two-period crossover studies. Single dose of EA4017 will be orally administered in the specified order (fasted/fed or fed/fasted). Part 5 (Japanese) is designed as multiple oral doses, placebo-controlled, randomized, asdending dose, double-blind study.
主要目的: Other

•Main inclusion criteria
•Non-smoking Japanese and Caucasian healthy adult males.
•Body Mass Index (BMI) at screening is below.
•Japanese: 18.5 or more but less than 25.0 kilogram per square metre (kg/m^2)
•Caucasian: 18.5 or more but less than 30.0 kilogram per square metre (kg/m^2)
•Written, informed consent to participate in the study based on the participant's own free will and able to comply with the requirements in the study.

•Main exclusion criteria
•With a surgical history at screening period that may affect the pharmacokinetics of the investigational product.
•Suspicion of having a clinically abnormal symptom or an organ impairment that requires treatments based on the history/complications at screening period or physical findings, vital signs, electrocardiogram findings, or laboratory values at screening or baseline period.
•A history of drug allergy at screening period.
•Judged by the investigator or subinvestigator to be inappropriate for the participation in this study.

发起方

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