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Summary
A Clinical Study to Evaluate the Safety, and Tolerability of BBM-P002 in the Treatment of Parkinson's Disease
NCTID
NCT07195825
(View at clinicaltrials.gov)
Description
The purpose of the study is to evaluate the safety and tolerability of BBM-P002 for stereotactic injection to treat participants with idiopathic Parkinson's Disease (PD) during the dose-limiting toxicity (DLT) observation period.
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Development Status
Active
Indication
Parkinson's Disease
Disease Ontology Term
DOID:14330
Compound Name
BBM-P002
Compound Alias
BBM003
Sponsor
Shanghai Xinzhi BioMed Co., Ltd.
Funder Type
Industry
Recruitment Status
Not yet recruiting
Enrollment Count
18 (ESTIMATED)
Results Posted
Not Available
Therapy Information
Target Gene/Variant
Undisclosed
Therapy Type
Undisclosed
Therapy Route
In-vivo
Mechanism of Action
Undisclosed
Route of Administration
Intraparenchymal
Drug Product Type
Viral vector
Target Tissue/Cell
Delivery System
Viral transduction
Vector Type
AAV
Editor Type
Dose 1
Undisclosed
Dose 2
Dose 3
Dose 4
Dose 5
Study Record Dates
Current Stage
Phase1
Submit Date
2025-09-10
Completion Date
2031-12-30
Last Update
2025-09-29
Participation Criteria
Eligible Age
40 Years - 70 Years
Standard Ages
Adult, Older adult
Sexes Eligible for Study
ALL
Locations
No.of Trial Sites
1
Locations
China
Regulatory Information
Has US IND
False
FDA Designations
Recent Updates
Resources/Links
Related NCTID
Early Phase 1: NCT05822739