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

ConditionPD
Trial statusRecruiting
Trial phasePhase 1
Trial typeInterventional
Biological sexAll
Age40-70
SponsorShanghai Xinzhi BioMed Co., Ltd.

About this trial

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.

Eligibility criteria

Qualifiers

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

Disqualifiers

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

Trial design

Treatments tested in this trial

  • Injecting BBM-P002 into the bilateral putamen

Treatment groups

18 Participants
are divided into 1 treatment group