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

JRCT ID: jRCT2071200110

Registered date:10/03/2021

Basic Information

• Recruitment status: Complete
• Health condition(s) or Problem(s) studied: Prevention of COVID-19
• Date of first enrollment: 15/03/2021
• Target sample size: 152
• Study type: Interventional
• Intervention(s): A intramuscular injection of DS-5670a (10, 30, 60 or 100 ug) or placebo twice in total.

Outcome(s)

Primary Outcome

- 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 Outcome

- Immunogenicity: 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: < 75age old
• Gender: Both

Include 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.

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 allergies 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