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: 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
RECRUITING
Phoenix
California
Belite Study Site - US05
RECRUITING
La Jolla
Belite Study Site - US09
RECRUITING
San Francisco
Florida
Belite Study Site - US06
RECRUITING
Miami
Massachusetts
Belite Study Site - US01
RECRUITING
Boston
Minnesota
Belite Study Site - US11
RECRUITING
Edina
Belite Study Site - US04
RECRUITING
Rochester
North Carolina
Belite Study Site - US02
RECRUITING
Durham
New York
Belite Study Site - US14
NOT_YET_RECRUITING
New York
Belite Study Site - US10
RECRUITING
Westbury
Pennsylvania
Belite Study Site - US07
NOT_YET_RECRUITING
Philadelphia
Texas
Belite Study Site - US13
NOT_YET_RECRUITING
Austin
Belite Study Site - US03
RECRUITING
Dallas
Belite Study Site - US12
RECRUITING
The Woodlands
Other Locations
Japan
Belite Study Site
RECRUITING
Kobe
Belite Study Site
RECRUITING
Kyoto
Belite Study Site
RECRUITING
Tokyo
United Kingdom
UK01 Belite Study Site
RECRUITING
London
Contact Information
Primary
Belite Bio Clinical Operations
clinicaltrial@belitebio.com
+886 972 080 097
Time Frame
Start Date: 2024-07-31
Estimated Completion Date: 2028-01
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