Safety and Tolerability Study of UBX1325 in Patients With Diabetic Macular Edema or Neovascular Age-Related Macular Degeneration
Last updated on July 2021Recruitment
- Recruitment Status
- Recruiting
- Estimated Enrollment
- Same as current
Summary
- Conditions
- Diabetic Macular Edema
- Neovascular Age Related Macular Degeneration
- Type
- Interventional
- Phase
- Phase 1
- Design
- Allocation: N/AIntervention Model: Single Group AssignmentMasking: None (Open Label)Primary Purpose: Treatment
Participation Requirements
- Age
- Between 50 years and 125 years
- Gender
- Both males and females
Description
This is a Phase 1, open-label, first-in-human (FIH), single-ascending dose (SAD) study consisting of approximately 4 cohorts. The total number of patients will be at least 3 per cohort plus 3 additional patients in the maximum tolerated dose (MTD) cohort in order to address the primary objective. Up...
This is a Phase 1, open-label, first-in-human (FIH), single-ascending dose (SAD) study consisting of approximately 4 cohorts. The total number of patients will be at least 3 per cohort plus 3 additional patients in the maximum tolerated dose (MTD) cohort in order to address the primary objective. Up to an additional 6 nAMD patients will be enrolled in the highest dose cohort. A single dose of UBX1325 will be administered intravitreally and all patients will be followed for approximately 6 months.
Tracking Information
- NCT #
- NCT04537884
- Collaborators
- Not Provided
- Investigators
- Study Chair: Jamie Dananberg, MD UNITY Biotechnology
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