A Phase 1 Study of S-892216 in Healthy Adults (COVID-19)

Gomez Juan Carlos0 个研究点目标入组 248 人开始时间: 2023年5月20日最近更新: 2023年10月17日

适应症

试验速览

暂无简介。

•Common in all parts
•-Participant must be 20 to 55 years of age inclusive, at the time of signing the informed consent form (ICF).
•-Apparently healthy as determined by medical evaluation including medical history, physical examination, laboratory tests, vital signs, and 12-lead ECG at screening and on admission. Or, determined to be eligible for participation by the investigator or subinvestigator in consideration of the safety in case for participants with clinical laboratory test results beyond the upper limit or below the lower limit of the reference range of the study site.
•-Body Mass Index (BMI) >= 18.5 and =< 30.0.
•-Male and female
•-Capable of giving signed informed consent as described in this protocol which includes compliance with the requirements and restrictions listed in the ICF and in this protocol.
•Only for part 1, 2, and 4
•-A person with Japanese parents.
•Only for Part 3
•-In Cohort H and J, a person with Japanese parents.
•-In Cohort K, a healthy adult White with White parents (regardless of nationality of the parents), who lives in Japan. Must possess Japanese citizenship, a special permanent resident certificate, or a residence card.

•Common in all parts
•-History of cardiovascular, respiratory, hepatic, renal, gastrointestinal, endocrinological, hematological, or neurological disorders that may significantly alter the absorption, metabolism, or elimination of drugs; determined to constitute a risk when administering the study intervention or to interfere with the interpretation of data.
•-In C-SSRS examined at screeing or on admission, 'Yes' to questions regarding suicidal ideation 1 to 5, or to questions regarding unintended self-injury behavior out of suicidal behavior, or judged as having risks for suicide in the opinion of the investigator.
•-At screeing or on admission, The total score of 10 points or more in PHQ-9.

发起方

Gomez Juan Carlos