Trials / Active Not Recruiting
Active Not RecruitingNCT07228559
A Study of Avoralstat In Participants With Diabetic Macular Edema
A Phase 1b Study to Evaluate the Safety, Tolerability, and Preliminary Efficacy of a Suprachoroidal Injection of Avoralstat In Participants With Diabetic Macular Edema
- Status
- Active Not Recruiting
- Phase
- Phase 1
- Study type
- Interventional
- Enrollment
- 9 (estimated)
- Sponsor
- BioCryst Pharmaceuticals · Industry
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
Summary
The goal of this study is to assess the safety and therapeutic potential of a single dose of avoralstat in adult participants with DME.
Detailed description
Study BCX4161-111 is an open-label, single ascending dose study with 24 weeks follow-up in participants with DME. Three cohorts with a minimum of 3 participants enrolled in each cohort with 3 dose levels of avoralstat (low, medium, high) are planned.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | avoralstat | BCX4161 for suprachoroidal injection |
Timeline
- Start date
- 2025-10-02
- Primary completion
- 2026-05-01
- Completion
- 2026-09-01
- First posted
- 2025-11-14
- Last updated
- 2026-04-07
Locations
8 sites across 2 countries: United States, Australia
Regulatory
- FDA-regulated drug study
Source: ClinicalTrials.gov record NCT07228559. Inclusion in this directory is not an endorsement.