Ignite Creation Date:
2024-05-06 @ 4:20 PM
Last Modification Date:
2024-10-26 @ 2:08 PM
Study NCT ID:
NCT04953078
Status:
COMPLETED
Last Update Posted:
2023-01-12
First Post:
2021-06-14
Brief Title:
A Study to Evaluate Safety Tolerability and Reactogenicity of an RBD-Fc-based Vaccine to Prevent COVID-19
Sponsor:
Baiya Phytopharm Co Ltd
Organization:
Baiya Phytopharm Co Ltd
Study Overview
Official Title:
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
Status Verified Date:
2023-01
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None