Clinical Trial

Disease: Herpes Simplex Virus Type I Stromal Keratitis, (NCT06474416)

Disease info:

Keratitis is an inflammation of the cornea, the clear, dome-shaped tissue on the front of your eye that covers the pupil and iris. Keratitis may or may not be associated with an infection. Non-infectious keratitis can be caused by a relatively minor injury, by wearing your contact lenses too long or by a foreign body in the eye. Infectious keratitis can be caused by bacteria, viruses, fungi and parasites.

HSV (Herpes Simplex Virus) keratitis is an infection of the cornea that is caused by HSV. The infection usually heals without damaging the eye, but more severe infections can lead to scarring of the cornea or blindness. HSV keratitis is a major cause of blindness worldwide. HSV-1, which is the type of HSV that also causes cold sores on the mouth, is the most common cause of corneal infections.

HSV is only found in humans and is spread through direct contact with someone who is infected with the virus. Most HSV keratitis infections happen after another part of the body, most commonly the mouth, has already been infected by HSV. HSV keratitis is often the result of a “flare up” (reactivation) of the earlier infection.

Frequency:
An estimated 3.7 billion people under age 50 (67%) have HSV-1 infection globally. An estimated 491 million people aged 15-49 (13%) worldwide have HSV-2 infection.
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
Who:

Contact

Name: Huixiang Ma, M.D.

Phone: +86-13777770073

Email: mahuixiang2002@163.com

Partners:
Locations:

China, Shanghai City

Huashan Hospital, Fudan University, Shanghai, Shanghai City, China, 200000


China, Zhejiang

The Second Affiliated Hospital, Zhejiang University School of Medicine, Hangzhou, Zhejiang, China, 310009


Eye Hospital of Wenzhou Medical University, Wenzhou, Zhejiang, China, 310009

Study start:
Sep. 4, 2023
Enrollment:
16 participants
Gene editing method:
CRISPR-Cas9
Type of edit:
Viral genome excision
Gene:
Viral genome (HSV-1)
Delivery method:
Lentivirus-like particle (VLP) - In-vivo
Indicator
IND Enabling Pre-clinical
Phase I Safety
Phase II Safety and Dosing
Phase III Safety and Efficacy

Status: Active recruiting

Description

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).

Last updated: Oct. 5, 2024
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