NCT06452316

Study to Evaluate the Safety and Efficacy of CSB-001 Ophthalmic Solution 0.1% in Subjects With Limbal Stem Cell Deficiency

An Open-Label Study Evaluating the Safety and Efficacy of CSB-001 Ophthalmic Solution 0.1% in Subjects With Limbal Stem Cell Deficiency

• Status: Recruiting
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 65 (estimated)
• Sponsor: Claris Biotherapeutics, Inc. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This study will enroll subjects with qualifying limbal stem cell deficiency (LSCD). All subjects will receive CSB-001 investigational drug in either one or both study eyes. The study is comprised of two identical phases (Dosing Phase I and II) of test article dosing separated by a 31- to 40-day period, the Dosing Holiday, where no test article is administered. Dosing Phase II is followed by an observational, noninterventional phase (Observation Phase).

Conditions

• Limbal Stem Cell Deficiency

Interventions

Type	Name	Description
BIOLOGICAL	CSB-001 Ophthalmic Solution 0.1%	CSB-001: human recombinant dHGF (5-amino acid deleted hepatocyte growth factor)

Timeline

• Start date: 2024-05-15
• Primary completion: 2027-12-31
• Completion: 2027-12-31
• First posted: 2024-06-11
• Last updated: 2026-04-07

Locations

6 sites across 1 country: United States

Regulatory

• FDA-regulated drug study