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NCT06452316 · ClinicalTrials.gov registry record · Phase 1
Study to Evaluate the Safety and Efficacy of CSB-001 Ophthalmic Solution 0.1% in Subjects With Limbal Stem Cell Deficiency
A Phase 1 study of Limbal Stem Cell Deficiency, sponsored by Claris Biotherapeutics.
- Recruiting
- Registry status
- Phase 1
- Development phase
- 65
- Enrollment target
- 6
- Study locations
NCT06452316: Recruiting Phase 1 study of Limbal Stem Cell Deficiency, sponsored by Claris Biotherapeutics.
NCT06452316 is a Phase 1 study of Limbal Stem Cell Deficiency that is actively recruiting participants, run by Claris Biotherapeutics. The registered enrollment target is 65 participants, roughly in line with the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target. The trial reports 6 study locations across 5 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT06452316, a Phase 1 study of Limbal Stem Cell Deficiency, is actively recruiting participants, sponsored by Claris Biotherapeutics.
- RECRUITING
- Registry status
- Phase 1
- Development phase
- 65 participants
- Enrollment target
- 6
- Study locations
Study 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).
Primary Outcome
Incidence of ocular and systemic adverse events
Conditions Studied
Interventions
- BIOLOGICAL CSB-001 Ophthalmic Solution 0.1%
Study Locations (6)
Indiana
- Midwest Cornea Associates, LLC - Carmel
- Francis Price Jr, MD - Indianapolis
California
- Loma Linda University Eye Institute - Loma Linda
Minnesota
- Minnesota Eye Consultants - Minnetonka
Oregon
- Legacy Devers Eye Institute - Portland
Texas
- Stuart A. Terry, MD PA - San Antonio
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 65 participants |
| Start Date | 2024-05-15 |
| Est. Completion | 2026-05 |
| Phase | Phase 1 |
What NCT06452316 shows while recruiting
NCT06452316 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 65 participants, a relatively small participant target, roughly in line with the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target.
The record links to 1 condition, with Limbal Stem Cell Deficiency appearing as the primary indexed condition, and to 1 intervention - of which CSB-001 Ophthalmic Solution 0.1% is the first listed.
NCT06452316 lists 6 locations in 5 states (Indiana, California, Minnesota).
Frequently Asked Questions
What is clinical trial NCT06452316 about?
NCT06452316 is a clinical study titled "Study to Evaluate the Safety and Efficacy of CSB-001 Ophthalmic Solution 0.1% in Subjects With Limbal Stem Cell Deficiency". 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 peri...
What is the current status of trial NCT06452316?
This trial is currently recruiting. It is a Phase 1 study. The enrollment target is 65 participants. The study started on 2024-05-15. Estimated completion is 2026-05.
What conditions does trial NCT06452316 study?
This clinical trial studies the following conditions: Limbal Stem Cell Deficiency.
What interventions are being tested in trial NCT06452316?
The interventions under investigation include: CSB-001 Ophthalmic Solution 0.1% (BIOLOGICAL).
Who is sponsoring clinical trial NCT06452316?
This trial is sponsored by Claris Biotherapeutics, which has 4 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT06452316 being conducted?
This trial has 6 study locations across California, Indiana, Minnesota, Oregon, Texas. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Where NCT06452316's enrollment target sits among peer trials
65 799th of 2000 higher than 1,193 of 2,000 other Phase 1 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 1 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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