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NCT06999733 · ClinicalTrials.gov registry record · Phase 1
A Study Comparing KB801 Verse Placebo in Patients With Stage 2 or 3 Neurotrophic Keratitis
A Phase 1 study of Neurotrophic Keratitis, sponsored by Krystal Biotech.
- Recruiting
- Registry status
- Phase 1
- Development phase
- 60
- Enrollment target
- 9
- Study locations
NCT06999733: Recruiting Phase 1 study of Neurotrophic Keratitis, sponsored by Krystal Biotech.
NCT06999733 is a Phase 1 study of Neurotrophic Keratitis that is actively recruiting participants, run by Krystal Biotech. The registered enrollment target is 60 participants, above the 14-participant average among 6 other Neurotrophic Keratitis trials with a reported enrollment target (329% higher). The trial reports 9 study locations across 7 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT06999733, a Phase 1 study of Neurotrophic Keratitis, is actively recruiting participants, sponsored by Krystal Biotech.
- RECRUITING
- Registry status
- Phase 1
- Development phase
- 60 participants
- Enrollment target
- 9
- Study locations
Study Summary
The Sponsor is developing KB801, a replication-defective, non-integrating herpes simplex virus type 1 (HSV-1)-derived vector engineered to deliver functional full-length human nerve growth factor (NGF) to the corneas of people with Stage 2 or 3 neurotrophic keratitis (NK) via topical application. This is a Phase 1/2, multicenter, double-masked, placebo-controlled study to evaluate the safety, tolerability, and preliminary efficacy of KB801 in these subjects.
Primary Outcome
Number of subjects with treatment related adverse events as assessed by CTCAE v5.
Conditions Studied
Interventions
- DRUG Placebo
- BIOLOGICAL KB801
Study Locations (9)
California
- UC Irvine Alpha Clinic - Irvine
- Azul Vision - California Eye Specialists Medical Group Inc. - Pasadena
Minnesota
- Vance Thompson Vision - Alexandria
- Minnesota Eye Consultants - Minnetonka
Indiana
- Midwest Cornea Associates - Carmel
Missouri
- St. Louis Eye Institute - Town and Country
New Jersey
- Metropolitan Eye Research and Surgery Institute - Palisades Park
North Dakota
- Vance Thompson Vision - West Fargo
Pennsylvania
- UPMC Vision Institute - Pittsburgh
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 60 participants |
| Start Date | 2025-07-07 |
| Est. Completion | 2027-12 |
| Phase | Phase 1 |
What NCT06999733 shows while recruiting
NCT06999733 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 60 participants, a relatively small participant target, above the 14-participant average among 6 other Neurotrophic Keratitis trials with a reported enrollment target (329% higher).
The record links to 1 condition, with Neurotrophic Keratitis appearing as the primary indexed condition, and to 2 interventions - of which Placebo is the first listed.
NCT06999733 lists 9 locations in 7 states (California, Minnesota, Indiana).
Frequently Asked Questions
What is clinical trial NCT06999733 about?
NCT06999733 is a clinical study titled "A Study Comparing KB801 Verse Placebo in Patients With Stage 2 or 3 Neurotrophic Keratitis". The Sponsor is developing KB801, a replication-defective, non-integrating herpes simplex virus type 1 (HSV-1)-derived vector engineered to deliver functional full-length human nerve growth factor (NGF) to the corneas of people with Stage 2 or 3 neurotrophic keratitis (NK) via topical application. Th...
What is the current status of trial NCT06999733?
This trial is currently recruiting. It is a Phase 1 study. The enrollment target is 60 participants. The study started on 2025-07-07. Estimated completion is 2027-12.
What conditions does trial NCT06999733 study?
This clinical trial studies the following conditions: Neurotrophic Keratitis.
What interventions are being tested in trial NCT06999733?
The interventions under investigation include: Placebo (DRUG), KB801 (BIOLOGICAL).
Who is sponsoring clinical trial NCT06999733?
This trial is sponsored by Krystal Biotech, which has 13 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT06999733 being conducted?
This trial has 9 study locations across California, Indiana, Minnesota, Missouri, New Jersey. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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