Phase 1/2Recruiting
Study to Evaluate ACDN-01 in ABCA4-related Stargardt Retinopathy (STELLAR)
ACDN-01-001: Open-Label, Single Ascending Dose Study to Evaluate the Safety, Tolerability, and Preliminary Efficacy of Subretinal ACDN-01 in Participants With ABCA4-related Retinopathy
- Sponsor
- Ascidian Therapeutics, Inc (Industry)
- Enrolment
- 15 planned
- Conditions
- Stargardt Disease; Cone Rod Dystrophy; Juvenile Macular Degeneration; Stargardt Disease 1
- Interventions
- ACDN-01
- Ages
- children, adults, older adults
- Registry
- NCT06467344
Full record on ClinicalTrials.gov
From the registry
This study is an open-label, single ascending dose clinical trial in participants who have ABCA4-related retinopathies. This is the first-in-human clinical trial in which ACDN-01 will be evaluated for safety, tolerability, and preliminary efficacy following a single subretinal injection of ACDN-01.
Primary outcomes
- Safety and tolerability of ACDN-01 as measured by the number and severity of adverse events and serious adverse events.
History
Study completion expected
Primary completion expected
Last registry update
Registered
Started