NCT06474442

A Phase Ⅱa Study of the Safety, Tolerability and Efficacy of BD111 in Herpes Simplex Virus Type I Stromal Keratitis

A Multicenter, Single-blind, Single-dose, Randomized, Phase Ⅱa Trial to Evaluate the Safety, Tolerability and Efficacy of Intrastromal BD111 Gene Editing Therapy in Adults With HSV-1 Stromal Keratitis

• Status: Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 40 (estimated)
• Sponsor: Shanghai BDgene Co., Ltd. · Industry
• Sex: All
• Age: 18 Years – 70 Years
• Healthy volunteers: Not accepted

Summary

This study aims to compare the clinical efficacy and safety of BD111 injection in combination with standard therapy vs. standard therapy in herpes simplex virus type I stromal keratitis (HSK), providing preliminary confirmation of the clinical effectiveness of BD111 in combination with standard therapy.

Detailed description

This is a phase Ⅱa, single-blind, single-dose, randomized, positively controlled clinical trial of BD111 in patients with herpes simplex virus type I stromal keratitis (HSK) aged 18 to 70 years. Forty eligible participants will be recruited in the trial. BD111 is investigational new biologics (Injection)--a type of lentiviral-like particle that can simultaneously deliver SpCas9 and gRNA targeting the HSV-1 virus gene, also known as HSV-1-erasing lentiviral particles (HELP). The total follow-up duration was 12 months, the safe endpoints and efficacy endpoints will be used to assess the efficacy, safety and tolerability profiles in patients with HSK.

Conditions

• Herpes Simplex Virus Type I Stromal Keratitis

Interventions

Type	Name	Description
GENETIC	BD111 Injection (investigational new drug)	BD111: intrastromally injection, single-dosing 10E6 TU/eye, specified injection volume is 0.15mL.
COMBINATION_PRODUCT	Triple-drugs therapy of HSV-1 stromal keratitis	Triple-drugs therapy: "Ganciclovir Eye gel+Valacilovir Tablets+Prednisolone Acetate Eye Drops" for 3 weeks.

Timeline

• Start date: 2025-04-28
• Primary completion: 2026-12-01
• Completion: 2027-03-01
• First posted: 2024-06-25
• Last updated: 2025-05-18

Locations

1 site across 1 country: China