NCT07195825RecruitingPhase 1
A Clinical Study to Evaluate the Safety, and Tolerability of BBM-P002 in the Treatment of Parkinson's Disease
A Single-arm, Open-label, Single-dose Clinical Study to Evaluate the Safety and Tolerability of BBM-P002 for Stereotactic Bilateral Putamen Injection in the Treatment of Idiopathic Parkinson's Disease
Source: ClinicalTrials.gov · Last updated 4 Aug 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Recruiting
- Phase (registry)
- Phase 1
- Study type
- Interventional
- Enrollment
- 18 (estimated)
- First submitted
- 10 Sept 2025
- Start date
- 27 Dec 2025
- Primary completion date
- 30 Dec 2027
- Lead sponsor
- Shanghai Xinzhi BioMed Co., Ltd.
- Diseases
- Parkinson disease
- NCT number
- NCT07195825
What you commit to
- Study type: Interventional · Phase 1
- Planned participants: 18
- From 27 Dec 2025 to the primary completion date, 30 Dec 2027
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Have contraindications for surgery or have previously undergone brain surgery
- Previous history of severe allergies
- 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.
Other illness
- The participants has an abnormal brain MRI suggestive of brain pathology other than Parkinson's disease
- 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
- Having a history of alcohol dependence or drug addiction
Other
- Atypical or secondary Parkinsonism
- Those with severe cognitive impairments
- Those with severe depression or severe anxiety
- Abnormal liver function
- Abnormal coagulation function
- Exclude those who have participated in other clinical trials within the past three months
- Pregnant or lactating female participants
- The situations that were determined by the investigator to be unsuitable for inclusion in the study
Who the study is looking for
- 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
Age in the registry: 40 years to 70 years · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Save your city in your profile to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Ruijin Hospital Affiliated to Shanghai Jiao Tong University School of Medicine Coordinator of this site? Confirm its status | Shanghai | China | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.