Status:
NOT_YET_RECRUITING
A Clinical Study to Evaluate the Safety, and Tolerability of BBM-P002 in the Treatment of Parkinson's Disease
Lead Sponsor:
Shanghai Xinzhi BioMed Co., Ltd.
Conditions:
PD
Eligibility:
All Genders
40-70 years
Phase:
PHASE1
Brief Summary
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 toxic...
Detailed Description
This is a single-arm, open-label study to evaluate the safety, tolerability, efficacy, pharmacokinetic, pharmacodynamic, and immune response of BBM-P002 within 52 weeks after into the bilateral putame...
Eligibility Criteria
Inclusion
- Participants with a diagnosis of Parkinson's disease for ≥ 5 years.
- The Hoehn-Yahr staging meets the requirements during the OFF periods.
- The MDS-UPDRS Part III score met the requirements during the OFF periods. the levodopa challenge test was positive
- During the screening period, participants were required to take the same stable dose of dopamine-releasing drugs (such as levodopa) regularly
- The participants agreed to postpone the neurosurgical procedures related to the indication treatment during the main study phase
- The participants agreed not to participate in any other therapeutic intervention studies during the trial period
- The participants agreed not to receive the vaccine during the main study phase
- From the screening period until at least 52 weeks after dosing, use a reliable contraceptive method
- The participants had good compliance and were able to undergo regular follow-ups. During the follow-up period, they were able to accurately complete the diary cards. Family members, guardians or caregivers could assist the subjects in filling out the diary cards
- Voluntarilyvoluntarily participated in the study and signed the informed consent form
Exclusion
- Atypical or secondary Parkinsonism
- Have contraindications for surgery or have previously undergone brain surgery
- The participants has an abnormal brain MRI suggestive of brain pathology other than Parkinson's disease
- Those with severe cognitive impairments
- Those with severe depression or severe anxiety
- Abnormal liver function
- Abnormal coagulation function
- Abnormalities in infectious disease screening
- Currently undergoing antiviral treatment for hepatitis
- Suffering from unstable or severe diseases in the cardiovascular, respiratory, digestive, nervous, hematological, immune and other systems
- Suffering from malignant tumors or having a history of tumors
- Previous history of severe allergies
- Exclude those who have participated in other clinical trials within the past three months
- Had received gene therapy during the screening period
- Select those who have received stem cell treatment within the past 12 months
- Exclude those who have used other investigational drugs within the past 4 weeks
- During the screening period, if the individual had received live vaccines within the previous 2 months, or had a history of vaccination within the last 30 days, they would be excluded.
- Having a history of alcohol dependence or drug addiction
- Pregnant or lactating female participants
- The situations that were determined by the investigator to be unsuitable for inclusion in the study
Key Trial Info
Start Date :
October 9 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 30 2031
Estimated Enrollment :
18 Patients enrolled
Trial Details
Trial ID
NCT07195825
Start Date
October 9 2025
End Date
December 30 2031
Last Update
September 29 2025
Active Locations (1)
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1
Ruijin Hospital Affiliated to Shanghai Jiao Tong University School of Medicine
Shanghai, Shanghai Municipality, China, 200025