Ontology highlight
ABSTRACT:
SUBMITTER: Ling LE
PROVIDER: S-EPMC6587432 | biostudies-literature | 2019 Apr
REPOSITORIES: biostudies-literature
Ling Leona E LE Hillson Jan L JL Tiessen Renger G RG Bosje Tjerk T van Iersel Mattheus Paulus MP Nix Darrell J DJ Markowitz Lynn L Cilfone Nicholas A NA Duffner Jay J Streisand James B JB Manning Anthony M AM Arroyo Santiago S
Clinical pharmacology and therapeutics 20181204 4
M281 is a fully human, anti-neonatal Fc receptor (FcRn) antibody that inhibits FcRn-mediated immunoglobulin G (IgG) recycling to decrease pathogenic IgG while preserving IgG production. A randomized, double-blind, placebo-controlled, first-in-human study with 50 normal healthy volunteers was designed to probe safety and the physiological maximum for reduction of IgG. Intravenous infusion of single ascending doses up to 60 mg/kg induced dose-dependent serum IgG reductions, which were similar acro ...[more]