Clinical Trial

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

Active, Not Recruiting Phase 1
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Record status
This record was last updated May 18, 2025 (before its estimated October 2025 completion). Its status may not reflect the trial's current state.
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).
Protocol Amendment History 2 amendments
This ClinicalTrials.gov record has been amended 2 times since 2024-06-19; most recent amendment 2025-05-14.
Status change: Recruiting → Active, Not Recruiting 2025-05-14
Trial Details
NCT Number NCT06474416
Lead Sponsor Shanghai BDgene Co., Ltd.
Conditions Herpes Simplex Virus Type I Stromal Keratitis
Enrollment 16 participants
Start Date 2023-09-04
Primary Completion 2025-10 (estimated)
Study Completion 2026-03-13 (estimated)
Updated on ClinicalTrials.gov 2025-05-18