Trials / Completed
CompletedNCT04298749
Safety and Tolerability of GX-P1 in Healthy Male Volunteers
A Randomized, Double Blind, Placebo-controlled, Dose-escalation Phase I Study to Investigate the Safety, Tolerability, and Pharmacokinetics/Pharmacodynamics of GX-P1 After Single IV Infusion in Healthy Male Volunteers
- Status
- Completed
- Phase
- Phase 1
- Study type
- Interventional
- Enrollment
- 24 (actual)
- Sponsor
- Genexine, Inc. · Industry
- Sex
- Male
- Age
- 19 Years – 45 Years
- Healthy volunteers
- Accepted
Summary
This study is a single-center, double-blind, placebo-controlled, phase I study with healthy male volunteers receiving ascending single dose of GX-P1
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | GX-P1 or Placebo (dose level 1) | GX-P1 dose level 1 or placebo |
| DRUG | GX-P1 or Placebo (dose level 2) | GX-P1 dose level 2 or placebo |
| DRUG | GX-P1 or Placebo (dose level 3) | GX-P1 dose level 3 or placebo |
Timeline
- Start date
- 2020-08-11
- Primary completion
- 2021-06-07
- Completion
- 2021-06-07
- First posted
- 2020-03-06
- Last updated
- 2021-07-27
Locations
1 site across 1 country: South Korea
Source: ClinicalTrials.gov record NCT04298749. Inclusion in this directory is not an endorsement.