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Clinical Trial Report

Gene Therapy Trial Report

Summary

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


NCTID NCT05657301 (View at clinicaltrials.gov)
Description
Development Status Active
Indication Neovascular (Wet) Age-Related Macular Degeneration (nAMD)
Disease Ontology Term DOID:10871
Compound Name KH631
Sponsor Chengdu Origen Biotechnology Co., Ltd.
Funder Type Industry
Recruitment Status
Recruiting
Enrollment Count 25
Results Posted Not Available

Therapy Information


Target Gene/Variant VEGFR1/R2 fusion protein
Therapy Type Gene transfer
Therapy Route In-vivo
Mechanism of Action Genetic delivery of therapeutic protein
Route of Administration Intravitreal
Drug Product Type Viral vector
Target Tissue/Cell
Delivery System Viral transduction
Vector Type AAV8
Editor Type none
Dose 1 5 undisclosed dose levels (200ul/dose)
Dose 2
Dose 3
Dose 4
Dose 5

Study Record Dates


Current Stage Phase1
Submit Date 2022-12-10
Completion Date 2027-09
Last Update 2024-02-26

Participation Criteria


Eligible Age 50 Years - 85 Years
Standard Ages Adult, Older adult
Sexes Eligible for Study ALL

Locations


No.of Trial Sites 7
Locations United States

Regulatory Information


Has US IND True
FDA Designations
Recent Updates 1st patient dosed 11/20/23

Resources/Links