Kanglin Biotechnology (Hangzhou) Co., Ltd.
To assess the safety and tolerability of single doses of KL002 over 78 weeks in subjects with Parkinson's disease。
This is an open-label, non-randomized, phase 1/2a single ascending dose study, consisting of Dose Escalation and Dose Expansion parts, to evaluate the safety, tolerability, and efficacy of KL002 in patients with Parkinson's disease. Eligible subjects will enter the dose escalation part of the study, receive a single stereotactic intraputaminal administration of KL002, and be followed for 18 months in the core study and up to 5 years total in long-term follow-up (LTFU) with safety and efficacy assessments.
Inclusion Criteria: 1. Males or females ≥ 40 and ≤ 75 years old 2. Diagnosis of Parkinson's disease per UK Parkinson's Disease Society Brain Bank Clinical Diagnostic Criteria 3. Duration of Parkinson's disease motor symptoms: 3-12 years 4. Hoehn and Yahr Stage II-IV (as determined in Practically Defined OFF state) 5. The OFF period MDS-UPDRS III score \> 30 ， and the percent improvement in MDS-UPDRS III in the levodopa/carbidopa challenge test is ≥ 30% 6. Must have been on a stable regimen of Parkinson's disease symptomatic therapy for at least 4 weeks prior to KL002 administration, and must…
KL002 is a recombinant adeno-associated virus (rAAV9) vector carrying TH, GCH1, and AADC genes
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