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

A Phase 1/2 study to assess the safety, immunogenicity and recommended dose of DS-5670a (COVID-19 Vaccine) in Japanese healthy adults and elderly subjects

Status

Active, not recruiting

Phases

Phase 2

Study type

Interventional

Source

JPRN

Registry ID

JPRN-jRCT2071200110

Enrollment

152

Registered

2021-03-10

Start date

2021-03-15

Completion date

Unknown

Last updated

2026-06-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Prevention of COVID-19

Interventions

A intramuscular injection of DS-5670a (10, 30, 60 or 100 ug) or placebo twice in total.

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1) Japanese 2) Healthy adults aged >=20 and =65 and =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

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.

Design outcomes

Primary

Measure	Time frame
- Safety: Adverse events, specific adverse events, laboratory data, weight, vital signs and 12-lead ECGs - Immunogenicity: Neutralizing antibodies against SARS-CoV-2 levels in blood	—

Secondary

Measure	Time frame
- Immunogenicity: Anti-IgG levels in blood - Pharmacokinetics: Plasma concentration of MAFB-7566a and constituent lipids of LNP	—

Contacts

Public ContactContact for Clinical Trial Information

DAIICHI SANKYO Co.,Ltd.

dsclinicaltrial@daiichisankyo.co.jp+81-3-6225-1111

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Jul 3, 2026