A Phase 1/2, Multicenter, Double-Masked, Placebo-Controlled Study of KB801 in Subjects With Stage 2 or 3 Neurotrophic Keratitis
Krystal Biotech, Inc.
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.
Description
Subjects will will be randomized 1:1 to receive KB801 or placebo (vehicle) topically to the study eye daily for 8 weeks. Subjects will return for a follow-up visit 2- weeks after finishing treatment to monitor for safety and durability of corneal healing. Safety follow-up visits will then occur every 3 months through approximately 1 year on study.
Eligibility
- Age range
- 18+ years
- Sex
- All
- Healthy volunteers
- No
Inclusion Criteria: 1. The subject must have read, understood, and signed an Institutional Review Board (IRB) approved Informed Consent Form and must be willing and able to comply with study procedures and instructions. 2. Aged ≥ 18 years at the time of informed consent. 3. Diagnosis of Stage 2 or Stage 3 NK, as defined by the Mackie criteria. 4. Persistent corneal epithelial defect (PCED) between Screening 1 and Screening 2 without clinical improvement during that time. PCED is defined as a focal loss of the cornea's outermost cell layer and can include involvement of the deeper stromal laye…
Interventions
- BiologicalKB801
Ophthalmic suspension of replication-defective, non-integrating herpes simplex virus type 1 (HSV-1)-based vector delivering functional, full-length human nerve growth factor (NGF)
- DrugPlacebo
Vehicle
Locations (9)
- UC Irvine Alpha ClinicIrvine, California
- Azul Vision - California Eye Specialists Medical Group Inc.Pasadena, California
- Midwest Cornea AssociatesCarmel, Indiana
- Vance Thompson VisionAlexandria, Minnesota
- Minnesota Eye ConsultantsMinnetonka, Minnesota
- St. Louis Eye InstituteTown and Country, Missouri