NCT07100171 Evaluation of GM101 Injection in Patients With Parkinson's Disease
| NCT ID | NCT07100171 |
| Status | Recruiting |
| Phase | EARLY_Phase 1 |
| Sponsor | Genemagic Biosciences Co., Ltd |
| Condition | Parkinson's Disease |
| Study Type | INTERVENTIONAL |
| Enrollment | 10 participants |
| Start Date | 2025-05-29 |
| Primary Completion | 2027-02-17 |
Trial Parameters
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Brief Summary
The objective of this study is to assess the safety of GM101 in participants with Parkinson's disease (PD)
Eligibility Criteria
Inclusion Criteria: 1. Clinically diagnosed patients with primary Parkinson's Disease \[in accordance with the "Diagnostic Criteria for Parkinson's Disease in China" released in 2016\]; 2. Participants must be able to comprehend (fully understand the details of the clinical trial and the potential risks and benefits of the study) and voluntarily sign the informed consent form. When participants are unable to read, the informed consent form and other written materials may be read by a legal representative or an impartial witness, who will also witness the consent process; 3. Age between 40 and 70 years old, inclusive, regardless of gender; 4. Body weight between 40 kg and 110 kg, and Body Mass Index (BMI) between 18 kg/m² and 34 kg/m²; 5. A history of Parkinson's Disease for \>= 5 years; 6. Able to undergo surgical anesthesia, suitable for neurosurgical procedures under anesthesia, and capable of undergoing CT/MRI examinations; 7. Hoehn-Yahr stage (Appendix IV Hoehn-Yahr Staging) at scr
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