Ignite Creation Date:
2024-05-06 @ 2:55 PM
Last Modification Date:
2024-10-26 @ 1:39 PM
Study NCT ID:
NCT04463472
Status:
COMPLETED
Last Update Posted:
2021-08-18
First Post:
2020-07-08
Brief Title:
Study of COVID-19 DNA Vaccine AG0301-COVID19
Sponsor:
AnGes Inc
Organization:
AnGes Inc
Study Overview
Official Title:
A Non-randomized Open-label Non-controlled Phase III Study to Assess Safety and Immunogenicity of Two Doses of Intramuscular AG0301-COVID19 1mg2mg in Healthy Adults
Status:
COMPLETED
Status Verified Date:
2021-08
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 will assess the safety and immunogenicity of AG0301-COVID19 in healthy adult volunteers
Detailed Description:
This is a Phase 12 single-center non-randomised open-label non-controlled trial Approximately 30 healthy volunteers male or female aged 20-65 will be enrolled in the low dose group for the first 15 and the high dose group for the remaining 15
Low dose group 10 mg AG0301-COVID19 intramuscular IM n 15 High dose group 20 mg AG0301-COVID19 IM n 15
Low dose group 10 mg AG0301-COVID19 intramuscular IM n 15 High dose group 20 mg AG0301-COVID19 IM n 15
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