Ignite Creation Date:
2024-05-06 @ 3:10 PM
Last Modification Date:
2024-10-26 @ 1:44 PM
Study NCT ID:
NCT04545749
Status:
COMPLETED
Last Update Posted:
2022-08-26
First Post:
2020-09-02
Brief Title:
A Study to Evaluate the Safety Tolerability and Immunogenicity of UB-612 COVID-19 Vaccine
Sponsor:
United Biomedical Inc Asia
Organization:
United Biomedical Inc Asia
Study Overview
Official Title:
A Phase I Open-label Study to Evaluate the Safety Tolerability and Immunogenicity of UB-612 Vaccine in Healthy Adult Volunteers
Status:
COMPLETED
Status Verified Date:
2022-02
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 is a phase I open-label dose-escalation clinical study to evaluate the safety tolerability and immunogenicity of 3 ascending doses of UB-612 COVID-19 vaccine in healthy adults aged from 20 to 55 years old
Detailed Description:
This is a phase I open-label dose-escalation clinical study to evaluate the safety tolerability and immunogenicity of 3 ascending doses of UB-612 COVID-19 vaccine in healthy adults Up to 60 subjects 20 subjects per group will be enrolled into this study Subjects in each group will be enrolled to receive two doses of UB-612 vaccine at 28-day interval Day 0 and Day 28
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