First-in-human assessment of PRX002, an anti-α-synuclein monoclonal antibody, in healthy volunteers.

ABSTRACT:

Background

α-Synuclein is a major component of pathologic inclusions that characterize Parkinson's disease. PRX002 is an antibody that targets α-synuclein, and its murine parent antibody 9E4 has been shown in preclinical studies to reduce α-synuclein pathology and to protect against cognitive and motor deteriorations and progressive neurodegeneration in human α-synuclein transgenic mice.

Methods

This first-in-human, randomized, double-blind, placebo-controlled, phase 1 study assessed the impact of PRX002 administered to 40 healthy participants in 5 ascending-dose cohorts (n = 8/cohort) in which participants were randomly assigned to receive a single intravenous infusion of study drug (0.3, 1, 3, 10, or 30 mg/kg; n = 6/cohort) or placebo (n = 2/cohort).

Results

PRX002

SUBMITTER: Schenk DB 

PROVIDER: S-EPMC5324684 | biostudies-literature | 2017 Feb

REPOSITORIES: biostudies-literature