A Double blind Phase 1/2 study of S-268019 (COVID-19)

agata Tsutae0 个研究点目标入组 60 人开始时间: 2021年8月23日最近更新: 2023年10月17日

试验速览

暂无简介。

•A person with Japanese parents.
•Apparently healthy as determined by medical assessment.
•Participant must be 20 to 64 years of age inclusive, at the time of signing the informed consent form (ICF).

•Positive SARS-CoV-2 antigen test result at Screening or before the first vaccination on Visit 1 (Day 1) .
•Presence of cardiovascular, respiratory, hepatic, renal, gastrointestinal, endocrinological, hematological, or neurological disorders that, in the opinion of the investigator/subinvestigator, will lead to a safety issue or interfere with the assessment of efficacy
•Body temperature higher than 37.5 degree Celsius on Day 1 before the vaccination.
•Positive SARS-CoV-2 antibody test result at Screening or a known history of SARS-CoV-2 infection by medical consultation on Day 1 before the vaccination
•Past use of vaccines approved or under development related to SARS-CoV-2 prior to the first vaccination.
•Past use of immunosuppressive drug within 6 months prior to the first vaccination.
•Hypersensitivity to any of the study drugs, or components thereof, or drug or other allergy that, in the opinion of the investigator/subinvestigator, contraindicates participation in the study (except pollinosis and atopic dermatitis).

发起方

agata Tsutae