臨床研究等提出・公開システム

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

A Phase 1/2 study of S-268019 in Japanese adult participants

Nagata Tsutae

Shionogi & Co., Ltd.

1-8, Doshomachi 3-chome, Chuo-ku, Osaka, Osaka

shionogiclintrials-admin@shionogi.co.jp

Corporate Communications Department

Shionogi & Co., Ltd.

1-8, Doshomachi 3-chome, Chuo-ku, Osaka, Osaka

+81-6-6209-7885

shionogiclintrials-admin@shionogi.co.jp

Not Recruiting

Dec. 11, 2020

Interventional

randomized controlled trial

double blind

placebo control

parallel assignment

prevention purpose

"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.

Both

COVID-19

S-268019 (intramuscular injection), Placebo (intramuscular injection)

Phase 1 Part-A, Phase 1 Part-B, and Phase 1 Part-C:
-The incidence of adverse events (AEs), adverse reactions, serious AEs (SAEs), solicited local reactogenicity AEs, and solicited systemic reactogenicity AEs
Phase 2 Part:
-Geometric mean titer (GMT) of SARS-CoV-2 neutralizing antibody titer

+81-6-6395-9000

Dec. 10, 2020

No

none