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ACTIVE NOT RECRUITING
NCT05657301
PHASE1

Safety and Tolerability of KH631 Gene Therapy in Participants With Neovascular Age-related Macular Degeneration

Sponsor: Chengdu Origen Biotechnology Co., Ltd.

View on ClinicalTrials.gov

Summary

VAN-2201 is Phase I clinical trial to assess the safety and tolerability of KH631 in subjects with neovascular AMD. KH631 is gene therapy designed to deliver a protein which targets and blocks VEGF via an adeno-associated viral vector. The standard of care for patients with neovascular AMD are anti-VEGF treaments, which have demonstrated improvement in vision and reduction in fluid. A one time placement of a product which inhibits VEGF has the potential to reduce the patient burden of regular intraocular injections.

Official title: A Phase I, Open-label, Multicenter, Dose-Escalating Study to Evaluate the Safety and Tolerability of KH631 Gene Therapy in Participants With Neovascular Age-related Macular Degeneration

Key Details

Gender

All

Age Range

50 Years - 85 Years

Study Type

INTERVENTIONAL

Enrollment

25

Start Date

2023-10-16

Completion Date

2027-09

Last Updated

2025-12-31

Healthy Volunteers

No

Interventions

DRUG

KH631

KH631: AAV vector containing a coding sequence for an anti-VEGF protein

Locations (7)

Kanghong Investigative Site

Phoenix, Arizona, United States

Kanghong Investigative Site

Lemont, Illinois, United States

Kanghong Investigative Site

Boston, Massachusetts, United States

Kanghong Investigative Site

Reno, Nevada, United States

Kanghong Investigative Site

Cherry Hill, New Jersey, United States

Kanghong Investigative Site

Germantown, Tennessee, United States

Kanghong Investigative Site

Dallas, Texas, United States