drugset
drugset / Trial / NCT06474416

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

NCT06474416 ↗

Phase 1 Active not recruiting 16 enrolled Shanghai BDgene Co., Ltd.
Non-randomizedSequentialOpen-labelTreatment

Summary

This Phase I study is intended to evaluate the safety, tolerability, PK/PD profiles and preliminary efficacy via corneal intrastromal administration in patients with herpes simplex virus-1 stromal keratitis (HSK), with a dose exploration of four ascending doses of BD111 (investigative drug product).

Timeline

Start
2023-09-04
Primary completion
2025-10
Completion
2026-03-13

Drugs

EvaluationDrugModalityDoseRoute
Subject BD111 CRISPR / gene editing 1.25e+06 unknown Other
Subject BD111 CRISPR / gene editing 2.5e+06 unknown Other
Subject BD111 CRISPR / gene editing 5e+06 unknown Other
Subject BD111 CRISPR / gene editing 1e+07 unknown Other
Subject Ganciclovir Small molecule — Topical
Subject Prednisolone Other / unclassified — Topical
Subject Valacyclovir Unknown — Oral

Indications

herpes simplex virus keratitis