A Phase 2 study to assess the safety, immunogenicity and recommended dose of DS-5670a in Japanese healthy adults

JRCT ID: jRCT2071210086

Registered date:29/10/2021

Basic Information

• Recruitment status: Complete
• Health condition(s) or Problem(s) studied: Prevention of infectious disease by Severe acute respiratory syndrome coronavirus 2(SARS-CoV-2)
• Date of first enrollment: 08/11/2021
• Target sample size: 80
• Study type: Interventional

Intervention(s)

Part 1 and Part 2: Administer 30 or 60 ug of DS-5670a intramuscularly twice.
3rd administration part: Administer 60 ug of DS-5670a intramuscularly once.

Outcome(s)

• Primary Outcome: Safety: Adverse events, specific adverse events, laboratory data, weight, vital signs and 12-lead ECGs

Secondary Outcome

Immunogenicity: Neutralizing antibodies against SARS-CoV-2 levels in blood, Anti-IgG levels in blood
Pharmacokinetics: Plasma concentration of MAFB-7566a and constituent lipids of LNP

Key inclusion & exclusion criteria

• Age minimum: >= 20age old
• Age maximum: < 65age old
• Gender: Both

Include criteria

1) Japanese
2) Healthy adults aged >=20 and <65 years at the time of informed consent (Part 1 and Part 2)
3) Body Mass Index (BMI) is >=17.5 and <30.0 kg/m^2 (at screening )
4) Subjects who can follow the compliance requirements during clinical trials, undergo medical examinations and tests specified by the protocol, and report symptoms, etc
5) Subjects who received DS-5670a 60 ug twice intramuscularly in Part 1 or Part 2 of this study and 6 months have passed (3rd administration part)

Exclude criteria

1) Having a history of anaphylaxis or severe allergies due to food, cosmetics, medicines, or vaccination.
2) Having alcohol or drug dependence.
3) Having a history of immunodeficiency or having a close relative with congenital immunodeficiency.
4) Having a history of SARS-CoV-2 infection.
5) Having fever of >=39.0 C or symptoms of suspected anaphylaxis such as systemic rash within 2 days after past vaccination.
etc.

Related Information

• Primary Sponsor: Inoguchi Akihiro
• Source(s) of Monetary Support: Japan Agency for Medical Research and Development