A Phase 1b Open-label Study to Evaluate the Pharmacokinetics, Pharmacodynamics, Safety, and Tolerability of Tinlarebant in Japanese Subjects With Stargardt Disease and a Phase 2/3 Randomized, Double-masked, and Placebo-controlled Study to Evaluate the Safety, Tolerability, and Efficacy of Tinlarebant in Subjects With Stargardt Disease
Status: Active_not_recruiting
Location: See all (18) locations...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 2/Phase 3
SUMMARY
The goal of this clinical trial is to evaluate the safety, tolerability, and efficacy of tinlarebant in subjects with Stargardt Disease
Eligibility
Participation Requirements
Sex: All
Minimum Age: 12
Maximum Age: 20
Healthy Volunteers: f
View:
• Subjects must have clinically diagnosed STGD1 with at least one mutation identified in the ABCA4 gene.
• Subjects must have a defined aggregate atrophic lesion in 1 or both eyes.
• Minimum BCVA is required in the study eye
Locations
United States
Arizona
Belite Study Site - US08
Phoenix
California
Belite Study Site - US05
La Jolla
Belite Study Site - US09
San Francisco
Florida
Belite Study Site - US06
Miami
Massachusetts
Belite Study Site - US01
Boston
Minnesota
Belite Study Site - US11
Edina
Belite Study Site - US04
Rochester
North Carolina
Belite Study Site - US02
Durham
New York
Belite Study Site - US14
New York
Belite Study Site - US10
Westbury
Pennsylvania
Belite Study Site - US07
Philadelphia
Texas
Belite Study Site - US13
Austin
Belite Study Site - US03
Dallas
Belite Study Site - US12
The Woodlands
Other Locations
Japan
Belite Study Site
Kobe
Belite Study Site
Kyoto
Belite Study Site
Tokyo
United Kingdom
UK01 Belite Study Site
London
Time Frame
Start Date: 2024-07-31
Completion Date: 2028-02
Participants
Target number of participants: 60
Treatments
Experimental: LBS-008, Tinlarebant
5 mg tablet taken orally once a day
Placebo_comparator: Placebo
Placebo tablets for tinlarebant 5 mg prepared similarly
Related Therapeutic Areas
Sponsors
Leads: Belite Bio, Inc