Two Phase 1, Randomized, Double-Blind, Placebo-Controlled, Single-Ascending-Dose Studies To Investigate the Safety, Tolerability, and Pharmacokinetics of an Anti-Influenza A Virus Monoclonal Antibody, MHAA4549A, in Healthy Volunteers

• Published in: Antimicrobial agents and chemotherapy Vol. 60; no. 9; pp. 5437 - 5444
• Main Authors: Lim, Jeremy J., Deng, Rong, Derby, Michael A., Larouche, Richard, Horn, Priscilla, Anderson, Malia, Maia, Mauricio, Carrier, Stephanie, Pelletier, Isabelle, Burgess, Tracy, Kulkarni, Priya, Newton, Elizabeth, Tavel, Jorge A.
• Format: Journal Article
• Language: English
• Published: United States American Society for Microbiology 01.09.2016
• Subjects: Adult; Antibodies, Monoclonal; Antibodies, Monoclonal - adverse effects; Antibodies, Monoclonal - pharmacokinetics; Antiviral Agents; Antiviral Agents - adverse effects; Antiviral Agents - pharmacokinetics; Drug Administration Schedule; Female; Gene Expression; Half-Life; Headache - diagnosis; Headache - etiology; Healthy Volunteers; Hemagglutinin Glycoproteins, Influenza Virus - genetics; Hemagglutinin Glycoproteins, Influenza Virus - metabolism; Humans; Influenza A virus; Influenza, Human - drug therapy; Influenza, Human - virology; Injections, Intravenous; Male; Middle Aged; Patient Safety

Hospitalized patients with severe influenza are at significant risk for morbidity and mortality. MHAA4549A is a human monoclonal immunoglobulin (Ig) G1 antibody that binds to a highly conserved stalk region of the influenza A virus hemagglutinin protein and neutralizes all tested seasonal human infl...