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A Phase 1/2 study to assess the safety, immunogenicity and recommended dose of DS-5670a in Japanese healthy adults and elderly subjects

Phase 1
Conditions
Prevention of COVID-19
Registration Number
JPRN-jRCT2071200110
Lead Sponsor
Inoguchi Akihiro
Brief Summary

Not available

Detailed Description

Not available

Recruitment & Eligibility

Status
Complete
Sex
All
Target Recruitment
152
Inclusion Criteria

1) Japanese
2) Healthy adults aged >=20 and <65 years, or healthy elderly aged >=65 and <75 years (at the time of informed consent)
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.

Exclusion 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 allergies such as systemic rash within 2 days after past vaccination.
etc.

Study & Design

Study Type
Interventional
Study Design
Not specified
Primary Outcome Measures
NameTimeMethod
- Safety: Adverse events, specific adverse events, laboratory data, weight, vital signs and 12-lead ECGs<br>- Immunogenicity: Neutralizing antibodies against SARS-CoV-2 levels in blood
Secondary Outcome Measures
NameTimeMethod
- Immunogenicity: Anti-IgG levels in blood<br>- Pharmacokinetics: Plasma concentration of MAFB-7566a and constituent lipids of LNP
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