Trials / Completed
CompletedNCT04463472
Study of COVID-19 DNA Vaccine (AG0301-COVID19)
A Non-randomized, Open-label, Non-controlled Phase I/II Study to Assess Safety and Immunogenicity of Two Doses of Intramuscular AG0301-COVID19 (1mg/2mg) in Healthy Adults
- Status
- Completed
- Phase
- Phase 1 / Phase 2
- Study type
- Interventional
- Enrollment
- 30 (actual)
- Sponsor
- AnGes, Inc. · Industry
- Sex
- All
- Age
- 20 Years – 65 Years
- Healthy volunteers
- Accepted
Summary
This study will assess the safety and immunogenicity of AG0301-COVID19 in healthy adult volunteers.
Detailed description
This is a Phase 1/2, 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: 1.0 mg AG0301-COVID19 intramuscular (IM) (n = 15) High dose group: 2.0 mg AG0301-COVID19 IM (n = 15)
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| BIOLOGICAL | AG0301-COVID19 | 1.0 mg of AG0301-COVID19 twice at 2-week intervals |
| BIOLOGICAL | AG0301-COVID19 | 2.0 mg of AG0301-COVID19 twice at 2-week intervals |
Timeline
- Start date
- 2020-06-29
- Primary completion
- 2020-09-28
- Completion
- 2021-08-12
- First posted
- 2020-07-09
- Last updated
- 2021-08-18
Locations
1 site across 1 country: Japan
Source: ClinicalTrials.gov record NCT04463472. Inclusion in this directory is not an endorsement.