A Phase 2/3 Study to Evaluate the Efficacy and Safety of Tinlarebant in Subjects With Stargardt Disease — DRAGON II

Stargardt Disease 1 Clinical Trial

Official title:
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 Not yet recruiting

Clinical Trial Summary

The goal of this clinical trial is to evaluate the safety, tolerability, and efficacy of tinlarebant in subjects with Stargardt Disease

Clinical Trial Description

This study will be comprised of a Phase 1b part conducted in Japan and a Phase 2/3 part. The Phase 1b part of the study will be open-label and will evaluate the pharmacokinetics (PK), pharmacodynamics (PD), safety, and tolerability of daily doses of 5 mg tinlarebant, administered for 7 days, in Japanese subjects with Stargardt Disease (STGD1). The Phase 2/3 part of the study will be randomized, double masked, and placebo controlled to evaluate the safety, tolerability, and efficacy of daily doses of 5 mg tinlarebant, administered for 24 months, in subjects with STGD1. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT06388083
Study type	Interventional
Source	Belite Bio, Inc
Contact	Belite Bio Clinical Operations
Phone	+886 972 080 097
Email	clinicaltrial@belitebio.com
Status	Not yet recruiting
Phase	Phase 2/Phase 3
Start date	June 2024
Completion date	July 2027

View Details

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