Pharmacokinetics and pharmacodynamics of mepolizumab, an anti-interleukin 5 monoclonal antibody, in healthy Japanese male subjects.

ABSTRACT: Interleukin 5 (IL-5) and eosinophils are thought to play an important role in the pathology of asthma. This study evaluated the pharmacokinetics, pharmacodynamics, safety, and tolerability of mepolizumab, a humanized anti-IL5 IgG1 monoclonal antibody, in development for the treatment of severe eosinophilic asthma. This single-blind study randomized 35 healthy Japanese male subjects (3:1) to receive either a single mepolizumab intravenous dose (10, 75, 250, or 750 mg) or placebo. Subjects were observed for up to 151 days postdose, depending on the dose administered. Blood samples were collected to measure mepolizumab concentrations, blood eosinophils, IL-5, and antibodies to mepolizumab. Mepolizumab exhibited dose-proportional pharmacokinetics. The terminal phase half-life was 19.7-34.6 day

SUBMITTER: Tsukamoto N 

PROVIDER: S-EPMC5042051 | biostudies-literature | 2016 Mar

REPOSITORIES: biostudies-literature