Safety and tolerability of multiple ascending doses of PRX002/RG7935, an anti–α-synuclein monoclonal antibody, in patients with Parkinson disease: A randomized clinical trial
JAMA Oct 15, 2018
Jankovic J, et al. - In patients with idiopathic Parkinson disease (PD), researchers assessed the safety and tolerability of multiple intravenous infusions of PRX002. This multicenter, randomized, double-blind, placebo-controlled, multiple ascending-dose trial included 80 participants aged 40-80 years with mild to moderate idiopathic PD (Hoehn and Yahr stages 1-3) who were randomized to six ascending-dose cohorts—PRX002 (0.3 mg/kg, 1.0 mg/kg, 3.0 mg/kg, 10 mg/kg, 30 mg/kg, or 60 mg/kg)—or placebo. The investigators found that single and multiple doses of PRX002 were generally safe and well tolerated, and led to robust binding of peripheral α-synuclein and dose-dependent increases of PRX002 in cerebrospinal fluid (CSF), reaching CSF levels that may be expected to engage extracellular aggregated α-synuclein in the brain.
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