Ignite Creation Date:
2024-07-17 @ 11:24 AM
Last Modification Date:
2024-10-26 @ 3:33 PM
Study NCT ID:
NCT06474416
Status:
RECRUITING
Last Update Posted:
2024-06-27
First Post:
2024-06-13
Brief Title:
A Study of the Safety Tolerability and Prelinminary Efficacy of BD111 in Herpes Simplex Virus Type I Stromal Keratitis
Sponsor:
Shanghai BDgene Co Ltd
Organization:
Shanghai BDgene Co Ltd
Study Overview
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
Status:
RECRUITING
Status Verified Date:
2024-06
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
This Phase I study is intended to evaluate the safety tolerability PKPD 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
Detailed Description:
Herpes simplex keratitis is an infectious diseases of the cornea that is primarily caused by Herpes Simplex Virus 1 HSV-1 The stromal type also known as HSV-1 stromal keratitis HSK is characterized by recurrent or chronic inflammation attributed to residual virus-triggered antigen-antibody-complement cascade reactions BD111 is a lentivirus-like particle that is an active drug substance delivering gRNA-expressing cassettes and SpCas9 mRNAThe mechanism of action MOA is based on CRISPRCas9 gene editing technology
This is a multicenter open-label dose-escalation Phase I trial to evaluate the safety tolerability PKPD profiles and preliminary efficacy of BD111 in patients with herpes simplex virus-1 stromal keratitis HSK in China About 16 patients will be enrolled dividing into open-label four dose groups and one positive control triple-drugs therapy group A rapid titration dose group combined with 33 dose escalation is designed for dose exploration
This is a multicenter open-label dose-escalation Phase I trial to evaluate the safety tolerability PKPD profiles and preliminary efficacy of BD111 in patients with herpes simplex virus-1 stromal keratitis HSK in China About 16 patients will be enrolled dividing into open-label four dose groups and one positive control triple-drugs therapy group A rapid titration dose group combined with 33 dose escalation is designed for dose exploration
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None