A Clinical Study to Evaluate the Safety, and Tolerability of BBM-P002 in the Treatment of Parkins… (NCT07195825) | Clinical Trial Compass
RecruitingPhase 1
A Clinical Study to Evaluate the Safety, and Tolerability of BBM-P002 in the Treatment of Parkinson's Disease
China18 participantsStarted 2025-12-27
Plain-language 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 toxicity (DLT) observation period.
Who can participate
Age range40 Years – 70 Years
SexALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
✓. 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
Exclusion criteria
✕. 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
What they're measuring
1
Incidence of dose limiting toxicity (DLT) events
Timeframe: Within 4 weeks
2
Incidence of Adverse Events (AEs) and Serious Adverse Events (SAEs)