drugset / Trial / NCT06474442

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

NCT06474442

Phase 2 Recruiting 40 enrolled Shanghai BDgene Co., Ltd.
RandomizedParallel-groupQuadruple-blindTreatment

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.

Timeline

Start
2025-04-28
Primary completion
2026-12
Completion
2027-03

Drugs

EvaluationDrugModalityDoseRoute
Subject BD111 CRISPR / gene editing 1e+07 unknown Other
Background Ganciclovir Small molecule Topical
Background Prednisolone Other / unclassified Topical
Background Valacilovir Unknown Oral

Indications