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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 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. The trial reports 6 study locations across 5 states.
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).
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 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT06452316
The ClinicalTrials.gov registry entry for NCT06452316 describes a study currently listed as recruiting, categorized as Phase 1. The registered enrollment target is 65 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Claris Biotherapeutics, which has 4 total studies on file at ClinicalTrials.gov.
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 reports 6 study locations spanning 5 distinct geographic areas - top geographies include 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.
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