NCT04953078

A Study to Evaluate Safety, Tolerability, and Reactogenicity of an RBD-Fc-based Vaccine to Prevent COVID-19

A Phase 1, Randomized, Open-label, Dose-Finding Study to Evaluate the Safety, Tolerability, and Reactogenicity of Escalating Doses of the Baiya SARS-CoV-2 Vax 1 Vaccine in Healthy Adults

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 48 (actual)
• Sponsor: Baiya Phytopharm Co., Ltd. · Industry
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Accepted

Summary

This study is a phase 1, open-label, randomized, first-in-human clinical trial to evaluate the safety, tolerability and reactogenicity of escalating doses of Baiya SARS-CoV-2 VAX1 vaccine in participants aged 18-60 for adult groups and 61-75 for elderly groups. Each group will consist of three cohorts to evaluate different doses (low, medium, high) of Baiya SARS-CoV-2 VAX vaccine. Participants will be injected with two doses of the investigational product with a 21-day interval.

Conditions

• Coronavirus

Interventions

Type	Name	Description
BIOLOGICAL	Baiya SARS-CoV-2 Vax 1	Intramuscular injection in the deltoid region of 0.5 mL/dose of Baiya SARS-CoV-2 Vax 1 (recombinant SARS-CoV-2 receptor-binding domain fused with FC region of human IgG1 vaccine)

Timeline

• Start date: 2021-09-11
• Primary completion: 2021-12-02
• Completion: 2022-11-04
• First posted: 2021-07-07
• Last updated: 2023-01-12

Locations

2 sites across 1 country: Thailand