Trials / Withdrawn
WithdrawnNCT03883945
A Safety and Efficacy Study to Evaluate Rosacea
A Randomized, Double-Blind, Vehicle-Controlled, Parallel-Group, Dose-Escalation Study to Evaluate the Safety and Pharmacokinetics of Intradermally Administered AIV001 in Subjects With Papulopustular Rosacea
- Status
- Withdrawn
- Phase
- Phase 1 / Phase 2
- Study type
- Interventional
- Enrollment
- 0 (actual)
- Sponsor
- AiViva BioPharma, Inc. · Industry
- Sex
- All
- Age
- 18 Years – 65 Years
- Healthy volunteers
- Not accepted
Summary
To evaluate the safety, efficacy, and pharmacokinetic profile of ascending concentrations of the study medication compared with vehicle in subjects with rosacea.
Detailed description
This is primarily a safety study to evaluate the safety of AIV001 when administered to subjects with rosacea. Exploratory efficacy measures will also be collected as well as pharmacokinetic profiles.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | AIV001 | intradermal injection |
| DRUG | Vehicle | intradermal injection |
Timeline
- Start date
- 2021-07-01
- Primary completion
- 2022-07-01
- Completion
- 2022-08-01
- First posted
- 2019-03-21
- Last updated
- 2024-12-17
Locations
1 site across 1 country: United States
Regulatory
- FDA-regulated drug study
Source: ClinicalTrials.gov record NCT03883945. Inclusion in this directory is not an endorsement.