A Clinical Study to Evaluate the Safety, and Tolerability of BBM-P002 in the Treatment of Parkinson's Disease

Recruiting now · Phase 1

Conditions studied: PD

In brief

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.

Key facts

Study ID

NCT07195825

Run by

Shanghai Xinzhi BioMed Co., Ltd.

People needed

18

Starts

2025-12-27

Expected to finish

2031-12-30

Last updated by the study team

2026-08-04

Who can join

Age: 40 and older, up to 70. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• Ruijin Hospital Affiliated to Shanghai Jiao Tong University School of Medicine — Shanghai, Shanghai Municipality, China (enrolling)

Full record on ClinicalTrials.gov

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