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

A Clinical Study to Evaluate the Safety, and Tolerability of BBM-P002 in the Treatment of Parkinson's Disease (NCT07195825) is a Phase 1 interventional studying PD, sponsored by Shanghai Xinzhi BioMed Co., Ltd.. RECRUITING as of the most recent ClinicalTrials.gov update. Talk to your doctor before contacting the trial site.

About This Trial

What Stage of Research Is This?

Phase 1 trials test a new treatment for the first time in humans, focusing on safety, dosing, and how the body processes the drug. For PD, a Phase 1 study typically enrolls a small number of participants — often healthy volunteers or patients who have exhausted standard treatment options. Phase 1 results determine whether a treatment moves into larger Phase 2 efficacy studies.

This trial is currently recruiting participants. The sponsor has registered the study with ClinicalTrials.gov as actively enrolling, which means new applicants who meet the eligibility criteria can be considered for screening. Trial status can change between updates — confirm current recruiting status with the study contact before traveling for a screening visit.

With a target enrollment of 18 participants, this is a small study — typical of early-phase research, rare-disease trials, or pilot studies designed to generate preliminary signal before a larger study is launched.

Who May Be Eligible (Plain English)

Who May Qualify: 1. Participants with a diagnosis of Parkinson's disease for ≥ 5 years. 2. The Hoehn-Yahr staging meets the requirements during the OFF periods. 3. The MDS-UPDRS Part III score met the requirements during the OFF periods. the levodopa challenge test was positive 4. During the screening period, participants were required to take the same stable dose of dopamine-releasing drugs (such as levodopa) regularly 5. The participants agreed to postpone the neurosurgical procedures related to the indication treatment during the main study phase 6. The participants agreed not to participate in any other therapeutic intervention studies during the trial period 7. The participants agreed not to receive the vaccine during the main study phase 8. From the screening period until at least 52 weeks after dosing, use a reliable contraceptive method 9. 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 10. Voluntarilyvoluntarily participated in the study and signed the willing to sign a consent form form Who Should NOT Join This Trial: 1. Atypical or secondary Parkinsonism 2. Have contraindications for surgery or have previously undergone brain surgery 3. The participants has an abnormal brain MRI suggestive of brain pathology other than Parkinson's disease 4. Those with severe cognitive impairments 5. Those with severe depression or severe anxiety 6. Abnormal liver function 7. Abnormal coagulation function 8. Abnormalities in infectious disease screening 9. Currently undergoing antiviral treatment for hepatitis 10. Suffering from unstable or severe diseases in the cardiovascular, respiratory, digestive, nervous, hematological, immune and other systems 11. Suffering from malignant tumors or having a history of tumors 12. Previous history of severe allergies ...See full criteria on ClinicalTrials.gov Always talk to your doctor about whether this trial is right for you.

These are translations of the protocol\'s inclusion and exclusion criteria, simplified for patients and caregivers. The original clinical text appears below. Eligibility is ultimately confirmed by the trial site\'s screening process — this summary is a starting point for a conversation with your doctor, not a final determination.

Original Eligibility Criteria

View original clinical language

Inclusion Criteria: 1. Participants with a diagnosis of Parkinson's disease for ≥ 5 years. 2. The Hoehn-Yahr staging meets the requirements during the OFF periods. 3. The MDS-UPDRS Part III score met the requirements during the OFF periods. the levodopa challenge test was positive 4. During the screening period, participants were required to take the same stable dose of dopamine-releasing drugs (such as levodopa) regularly 5. The participants agreed to postpone the neurosurgical procedures related to the indication treatment during the main study phase 6. The participants agreed not to participate in any other therapeutic intervention studies during the trial period 7. The participants agreed not to receive the vaccine during the main study phase 8. From the screening period until at least 52 weeks after dosing, use a reliable contraceptive method 9. 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 10. Voluntarilyvoluntarily participated in the study and signed the informed consent form Exclusion Criteria: 1. Atypical or secondary Parkinsonism 2. Have contraindications for surgery or have previously undergone brain surgery 3. The participants has an abnormal brain MRI suggestive of brain pathology other than Parkinson's disease 4. Those with severe cognitive impairments 5. Those with severe depression or severe anxiety 6. Abnormal liver function 7. Abnormal coagulation function 8. Abnormalities in infectious disease screening 9. Currently undergoing antiviral treatment for hepatitis 10. Suffering from unstable or severe diseases in the cardiovascular, respiratory, digestive, nervous, hematological, immune and other systems 11. Suffering from malignant tumors or having a history of tumors 12. Previous history of severe allergies 13. Exclude those who have participated in other clinical trials within the past three months 14. Had received gene therapy during the screening period 15. Select those who have received stem cell treatment within the past 12 months 16. Exclude those who have used other investigational drugs within the past 4 weeks 17. 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. 18. Having a history of alcohol dependence or drug addiction 19. Pregnant or lactating female participants 20. The situations that were determined by the investigator to be unsuitable for inclusion in the study

Treatments Being Tested

GENETIC

Injecting BBM-P002 into the bilateral putamen

BBM-P002 is an AAV-based gene therapy that delivers a therapeutic gene cassette into putamen for the treatment of Parkinson's Disease

Locations (1)

Trial sites listed on ClinicalTrials.gov for this study. Site activation status can vary — confirm with the specific site before traveling for a screening visit.

Ruijin Hospital Affiliated to Shanghai Jiao Tong University School of Medicine

Shanghai, Shanghai Municipality, China

How to Talk to Your Doctor About This Trial

Bring the printable summary of this trial — including the NCT ID (NCT07195825), the sponsor (Shanghai Xinzhi BioMed Co., Ltd.), and the key eligibility criteria — to your next appointment. Your doctor can review the inclusion and exclusion criteria against your medical history, lab values, and current treatments to assess whether you are likely to qualify. They can also help you weigh whether trial participation makes sense alongside your existing care plan.

Useful questions to walk through together: What does the trial protocol require beyond standard care? How long is the active treatment phase, and how long is follow-up? Are there study visits at sites I can reach? Who pays for the trial-specific procedures, and who pays for standard-of-care portions? See our 25 questions to ask about clinical trials guide for a more complete checklist.

Authoritative Sources

The official record for this trial lives on ClinicalTrials.gov — the federal registry maintained by the National Library of Medicine at NIH. For background on how this trial fits into the FDA approval pathway, see the FDA drug approval process. For oncology-specific guidance for patients considering trials, the National Cancer Institute publishes patient-oriented overviews. International trial registries are aggregated by the WHO ICTRP.

Frequently Asked Questions

What is the NCT07195825 clinical trial studying?

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. The full protocol is registered on ClinicalTrials.gov and includes the primary outcome measures, eligibility criteria, and study endpoints.

Who can participate in NCT07195825?

Eligibility for this trial depends on the specific inclusion and exclusion criteria set by the sponsor. The plain-English summary above translates the most important criteria into accessible language; the official clinical text is preserved in the collapsible section underneath. Whether you fit any specific trial is a medical decision your doctor needs to confirm — bring the trial information to your treating physician for a full review against your medical history.

How do I contact the trial site for NCT07195825?

Contact information registered with ClinicalTrials.gov is shown in the sidebar of this page. Before reaching out, confirm with your treating physician that this trial is appropriate for your situation. The trial site will then walk you through the screening process to determine final eligibility.

Is participating in a clinical trial safe?

Clinical trials in the United States are regulated by the FDA and overseen by Institutional Review Boards (IRBs) that review the protocol for safety. Risk varies by trial — Phase 1 studies test new treatments in humans for the first time, while Phase 3 trials use treatments that have already passed earlier safety screening. The informed consent document for any specific trial details the known risks and what to expect. Discuss those risks with your physician before deciding whether to participate.

Where can I verify the data on this page?

Every detail on this page comes directly from the ClinicalTrials.gov API. Click "View on ClinicalTrials.gov" in the sidebar to see the official, unmodified record. The federal record is always authoritative; this page is a structured presentation with a plain-English eligibility translation. For background on how clinical trials are regulated, see the FDA drug approval process documentation.

How This Page Is Built

Every field on this page is pulled directly from the ClinicalTrials.gov API v2 — no estimates, no proxies. The plain-English eligibility translation is generated from the original protocol text and reviewed for fidelity to the underlying clinical criteria. The original clinical text remains visible in the collapsible section above so users and clinicians can verify the translation. Read the full methodology for the data pipeline and known limitations.

Source: ClinicalTrials.gov API v2 record for NCT07195825. Maintained by the National Library of Medicine at NIH. Public domain. Cite as: "TrialFinderData. NCT07195825. Data: ClinicalTrials.gov."

Medical disclaimer: This page is informational, not medical advice. Talk to your doctor about whether a clinical trial is right for you.

Last updated 2026-05-08 · Data from ClinicalTrials.gov.