MedTrace Logo

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

NCT06474442 · Status: RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 40

Last updated 2025-05-18

No results posted yet for this study

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.

Conditions

  • Herpes Simplex Virus Type I Stromal Keratitis

Interventions

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.

Sponsors & Collaborators

  • Shanghai BDgene Co., Ltd.

    lead INDUSTRY

Principal Investigators

  • Fujun Li, M.D. · Shanghai BDgene Co., Ltd.

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
70 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-04-28
Primary Completion
2026-12-31
Completion
2027-03-31

Countries

  • China

Study Locations

More Related Trials

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06474442 on ClinicalTrials.gov