drugset / Trial / NCT04953078

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

NCT04953078 ↗

RandomizedSequentialOpen-labelPrevention

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.

Timeline

Start
2021-09-11
Primary completion
2021-12-02
Completion
2022-11-04

Drugs

EvaluationDrugModalityDoseRoute
Subject Baiya SARS-CoV-2 Vax 1 Vaccine 10 ug Intramuscular
Subject Baiya SARS-CoV-2 Vax 1 Vaccine 50 ug Intramuscular
Subject Baiya SARS-CoV-2 Vax 1 Vaccine 100 ug Intramuscular