A Single-arm, Open-label, Single-center Trial, Evaluating the Safety and Efficacy of BBM-P002 for Primary Advanced Parkinson's Disease

BBM003- IIT1003

Safety and Efficacy Study of BBM-P002 in subjects with primary advanced Parkinson's disease

2023-04-28

2025-05-30

2028-12-30

Not yet recruiting

Early phase I

6

Inclusion Criteria: 1. Diagnosed with idiopathic Parkinson's disease. 2. Males and females, 40 to 70 years of age (inclusive). 3. Disease duration from diagnosis of ≥5 years. Responsiveness to dopamine. 4. Good compliance and regular follow-up. Completion of Parkinson's disease patient diary accurately during follow-up, and family members, guardians or caregivers can help subjects fill in patient diary. Exclusion Criteria: 1. Atypical or secondary parkinsonism. 2. History of coagulopathy, abnormal bleeding or hemopathy family history. Other bleeding risk which increases risk of surgery determined by investigator. 3. Any type of prior gene therapy. 4. Clinically significant electrocardiogram (ECG) abnormalities. 5. Concomitant disease including unstable cardiovascular and cerebrovascular diseases within 3 months, uncontrolled hypertension, sever postural hypotension, poorly controlled diabetes, history of malignancy. 6. Acute or chronic: hepatitis B (HBV); hepatitis C (HCV) infection must have completed curative antiviral treatment with HBV/HCV viral load below the limit of quantification or be negative due to prior treatment or natural resolution to be eligible for enrollment. Subject with Human Immunodeficiency Virus (HIV) or Syphilitic serum positive should be excluded.

{'studyType': 'INTERVENTIONAL', 'phases': ['EARLY_PHASE1'], 'designInfo': {'allocation': 'NA', 'interventionModel': 'SINGLE_GROUP', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'NONE'}}, 'enrollmentInfo': {'count': 6, 'type': 'ESTIMATED'}}

2023-04-21