Safety, tolerability, pharmacokinetics, and immunogenicity of a human monoclonal antibody targeting the G glycoprotein of henipaviruses in healthy adults: a first-in-human, randomised, controlled, phase 1 study

• Published in: The Lancet infectious diseases Vol. 20; no. 4; pp. 445 - 454
• Main Authors: Playford, Elliott Geoffrey, Munro, Trent, Mahler, Stephen M, Elliott, Suzanne, Gerometta, Michael, Hoger, Kym L, Jones, Martina L, Griffin, Paul, Lynch, Kathleen D, Carroll, Heidi, El Saadi, Debra, Gilmour, Margaret E, Hughes, Benjamin, Hughes, Karen, Huang, Edwin, de Bakker, Christopher, Klein, Reuben, Scher, Mark G, Smith, Ina L, Wang, Lin-Fa, Lambert, Stephen B, Dimitrov, Dimiter S, Gray, Peter P, Broder, Christopher C
• Format: Journal Article
• Language: English
• Published: United States Elsevier Ltd 01.04.2020; Elsevier B.V; Elsevier Limited
• Subjects: Adults; Analysis; Antibodies; Binding sites; Biological products; Clinical trials; Disease; Dosage; Encephalitis; Epidemics; Fatalities; Glycoproteins; Headache; Health services; Horses; Immunogenicity; In vivo methods and tests; Infections; Infectious diseases; Intravenous administration; Intravenous infusion; Medical research; Monoclonal antibodies; Pharmacokinetics; Pharmacology; R&D; Research & development; Safety; Viral infections; Viruses; Bangladesh; Malaysia; Queensland Australia; Australia

The monoclonal antibody m102.4 is a potent, fully human antibody that neutralises Hendra and Nipah viruses in vitro and in vivo. We aimed to investigate the safety, tolerability, pharmacokinetics, and immunogenicity of m102.4 in healthy adults. In this double-blind, placebo-controlled, single-centre...