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

StatusActive, Not Recruiting
PhasePhase 1
Started
View on ClinicalTrials.gov ↗
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.

Record History

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  1. Trial status: Recruiting to Active, Not Recruiting
    • Primary completion date: Sep 2025 to Oct 2025
    • Study completion date: Sep 2025 to Mar 13, 2026
    • Site details revised at 3 of 3 sites
    v3
  2. Study sites: 2 to 3
    • Study title shortened, about 1 word
    v2
  3. Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
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).
Trial Details
NCT Number NCT06474416
Lead Sponsor Shanghai BDgene Co., Ltd.
Conditions
(from sponsor)		 Herpes Simplex Virus Type I Stromal Keratitis
Related terms Keratitis, Herpetic
Enrollment 16 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov