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Gene Therapy Trial Report

Summary

A Trial to Evaluate Safety and Efficacy of a Product Named VGN-R09b in Patients With Parkinson's Disease

NCTID NCT06480461 (View at clinicaltrials.gov)
Description
Development Status Active
Indication Parkinson's Disease
Disease Ontology Term DOID:14330
Compound Name VGN-R09b
Compound Description AADC + NTF
Sponsor Shanghai Vitalgen BioPharma Co., Ltd.
Funder Type Industry
Recruitment Status
Not yet recruiting
Enrollment Count 39 (ESTIMATED)
Results Posted Not Available

Therapy Information

Target Gene/Variant DDC
Therapy Type Gene transfer
Therapy Route In-vivo
Mechanism of Action Overexpression of protective allele/gene
Route of Administration Intraparenchymal
Drug Product Type Viral vector
Target Tissue/Cell Striatum
Delivery System Viral transduction
Vector Type AAV9
Editor Type none
Dose 1 8.0E11 vg
Dose 2 1.6E12 vg
Dose 3 3.2E12 vg
Dose 4
Dose 5

Study Record Dates

Current Stage Phase1, Phase2
Submit Date 2024-06-14
Completion Date 2031-07-01
Last Update 2024-06-28

Participation Criteria

Eligible Age 40 Years - 75 Years
Standard Ages Adult, Older adult
Sexes Eligible for Study ALL

Locations

No.of Trial Sites
Locations

Regulatory Information

Has US IND False
FDA Designations Fast Track
Recent Updates IND cleared in July 2024

Resources/Links

Clinical Publications
News and Press Releases