A Phase 1/2 study of S-268019 in Japanese adult participants
- Conditions
- COVID-19
- Registration Number
- JPRN-jRCT2051200092
- Lead Sponsor
- agata Tsutae
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 300
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.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Phase 1 Part-A, Phase 1 Part-B, and Phase 1 Part-C:<br>-The incidence of adverse events (AEs), adverse reactions, serious AEs (SAEs), solicited local reactogenicity AEs, and solicited systemic reactogenicity AEs<br>Phase 2 Part:<br>-Geometric mean titer (GMT) of SARS-CoV-2 neutralizing antibody titer
- Secondary Outcome Measures
Name Time Method