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ACTIVE NOT RECRUITING
NCT06474416
PHASE1

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

Sponsor: Shanghai BDgene Co., Ltd.

View on ClinicalTrials.gov

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

GENETIC

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).

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.

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