NCT05113849

Study to Evaluate the Safety and Immunogenicity of SARS-CoV-2 Vaccine (IN-B009) in Healthy Adults (COVID-19)

A Phase 1, Open-label, Dose-escalation Study to Assess the Safety, Reactogenicity, and Immunogenicity of a SARS-CoV-2 Vaccine (IN-B009) in Healthy Adults Aged at 19 to 55 Years

• Status: Unknown
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 40 (estimated)
• Sponsor: HK inno.N Corporation · Industry
• Sex: All
• Age: 19 Years – 55 Years
• Healthy volunteers: Accepted

Summary

This is a first in human, phase I, open-label, dose-escalation study to assess the safety, reactogenicity, and immunogenicity of a SARS-CoV-2 Vaccine (IN-B009) in healthy adults.

Detailed description

Total of 40 participants will be enrolled in 3 institutions : Seoul National University Hospital, Jeonbuk National University Hospital, and Chungbuk National University Hospital. Safety, reactogenicity, and immunogenicity will be evaluated in healthy participants with administration of IN-B009 (Injected twice, 21-day-interval).

Conditions

• COVID-19

Interventions

Type	Name	Description
BIOLOGICAL	IN-B009 (Low-dose)	Two doses, intramuscular injection
BIOLOGICAL	IN-B009 (High-dose)	Two doses, intramuscular injection

Timeline

• Start date: 2021-09-16
• Primary completion: 2023-02-01
• Completion: 2023-02-01
• First posted: 2021-11-09
• Last updated: 2021-11-09

Locations

3 sites across 1 country: South Korea