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Clinical Trial Report

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
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
Recent Updates

Resources/Links