Abstract
GNbAC1 is a humanized IgG4 monoclonal antibody antagonist of Mulitple Sclerosis Retrovirus Envelope (MSRV-Env), a protein that could play a critical role in multiple sclerosis. This randomized placebo-controlled dose-escalation study evaluated the safety and pharmacokinetics of GNbAC1 in 21 healthy volunteers after single intravenous infusion at doses of 6, 18 and 36 mg/kg. Lumbar punctures were performed at days 2, 15 or 29 to measure GNbAC1 concentrations in cerebrospinal fluid (CSF). GNbAC1 was well tolerated. Serum data show a dose-linear pharmacokinetics. A mean CSF/serum ratio of 0.12% was observed at Day 2, increasing to 0.39% at Day 15 and 0.42% at Day 29. Linear regression analysis shows a relationship between GNbAC1 CSF/serum ratio and albumin CSF/serum ratio and a relationship at the limit of statistical significance with the timing of CSF sampling.
Learn how BioAgilytix provides the
See how our PK expertise complements our immunogenicity services by evaluating
Learn why we’re a trusted partner to
What are your specific assay needs? Let’s schedule a conversation to review your
questions and requirements with one of our scientists.
Learn how BioAgilytix provides the
See how our PK expertise complements our immunogenicity services by evaluating
Learn why we’re a trusted partner to
What are your specific assay needs? Let’s schedule a conversation to review your
questions and requirements with one of our scientists.
Services
Copyright © 2021 BioAgilytix Labs. All rights reserved.