drugset / Trial / NCT04953078
A Study to Evaluate Safety, Tolerability, and Reactogenicity of an RBD-Fc-based Vaccine to Prevent COVID-19
Phase 1
Completed
48 enrolled
Baiya Phytopharm Co., Ltd.
National Vaccine Institute, Thailand · collab
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
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| 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 |