Safety and Efficacy Study of Parkinson's Disease Gene Therapy Drug (BBM-P002)

• Status: Not yet recruiting
• Trial end date: 2028-12-30
• Target enrollment: 0
• Participant gender: All

Summary

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

• Phase: Early Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Xiangya Hospital of Central South University

Criteria

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.