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
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.
• 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