A study to evaluate safety, tolerability, and pharmacokinetics of a single intravitreal injection of UBX1325 in patients diagnosed with diabetic macular edema (DME) or neovascular Age-Related Macular Degeneration.
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.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
19
Investigational drug intravitreal injection
Retina-Vitreous Associates Medical Group
Beverly Hills, California, United States
Salehi Retina Institute
Huntington Beach, California, United States
MedEye Associates
Miami, Florida, United States
Sarasota Retina Institute
Sarasota, Florida, United States
Ocular and systemic safety and tolerability of a single intravitreal injection of UBX1325 evaluated by the incidence of dose limiting toxicities (DLTs) and treatment emergent adverse events (TEAEs)
Time frame: 24 weeks
Plasma concentration of UBX1325 following a single intravitreal injection
Time frame: up to 24 hours post dose
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Center for Retina and Macular Disease
Winter Haven, Florida, United States
MidWest Eye Institute
Indianapolis, Indiana, United States
Houston Eye Associates
Houston, Texas, United States
Medical Center Ophthalmology Associates
San Antonio, Texas, United States