A Phase 1/2, randomized, double-blind, placebo-controlled, parallel-group study of S-268019 in Japanese adult participants

agata Tsutae0 个研究点目标入组 300 人开始时间: 2020年12月9日最近更新: 2023年10月17日

试验速览

暂无简介。

•Phase 1 Part-A:
•-A person with Japanese nationality.
•-Participant must be 20 to 64 years of age inclusive, at the time of signing the informed consent form (ICF).
•-Apparently healthy as determined by medical assessment.
•-Body mass index (BMI) within the range 18.5 to 25.0 (inclusive) at Screening.
•Phase 1 Part-B:
•-A person with Japanese nationality.
•-Participant must be 65 years of age or above, at the time of signing the ICF.
•-BMI within the range 18.5 to 30.0 (inclusive) at Screening.
•Phase 1 Part-C:
•-A person with Japanese nationality.
•-Participant must be 20 to 64 years of age inclusive, at the time of signing the informed consent form (ICF).
•-Apparently healthy as determined by medical assessment.
•-BMI within the range 18.5 to 30.0 (inclusive) at Screening.
•Phase 2 Part:
•-A person with Japanese nationality.
•-Participant must be 20 to 64 years of age inclusive, at the time of signing the ICF.
•-BMI within the range 18.5 to 30.0 (inclusive) at Screening. et, al.

•Common to Phase 1 Part-A, Phase 1 Part-B, Phase 1 Part-C, and Phase 2 Part:
•-Positive SARS-CoV-2 antigen test result at Screening.
•-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.
•-Past use of vaccines related to SARS-CoV-2 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).
•Phase 1 Part-A and Phase 1 Part-C:
•-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 immunosuppressive drug within 6 months prior to the first vaccination.
•The following applies to Phase 1 Part-B and Phase 2 Part:
•-Immunosuppressed state [immunocompromised, with acquired immunodeficiency syndrome (AIDS), receiving systemic steroid or immunosuppressive drugs, being treated for malignancy or receiving other immunosuppressive therapy]. et, al.

发起方

agata Tsutae