Clinical Research Directory
Browse clinical research sites, groups, and studies.
A Study of the Safety, Tolerability and Prelinminary Efficacy of BD111 in Herpes Simplex Virus Type I Stromal Keratitis
Sponsor: Shanghai BDgene Co., Ltd.
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).
Official title: A Multicenter, Open-label, Single Dose, Phase Ⅰ Trial to Evaluate the Safety, Tolerability and Prelinminary Efficacy of BD111 in Patients With Herpes Simplex Virus Type I Stromal Keratitis in China
Key Details
Gender
All
Age Range
18 Years - 70 Years
Study Type
INTERVENTIONAL
Enrollment
16
Start Date
2023-09-04
Completion Date
2026-03-13
Last Updated
2025-05-18
Healthy Volunteers
No
Interventions
BD111 Injection (Investigative New Drug)
BD111 Injection (Investigative New Drug) is a type of lentiviral-like particle, which can simultaneously deliver SpCas9 and gRNA targeting the HSV-1 virus gene, also known as HSV-1-erasing lentiviral particles (HELP).
Triple-drugs therapy of HSV-1 stromal keratitis
Triple-drugs therapy: "Ganciclovir Eye gel+Valacilovir Tablets+Prednisolone Acetate Eye Drops" for 3 weeks.
Locations (3)
Huashan Hospital, Fudan University
Shanghai, Shanghai City, China
The Second Affiliated Hospital, Zhejiang University School of Medicine
Hangzhou, Zhejiang, China
Eye Hospital of Wenzhou Medical University
Wenzhou, Zhejiang, China