A Study of MHAA4549A to Assess Safety And Pharmacokinetics in Healthy Volunteers

Phase 1 Completed 21 enrolled Genentech, Inc.

RandomizedParallel-groupDouble-blind

Summary

This randomized, double-blind, placebo-controlled, single-ascending dose study will assess the safety, tolerability and pharmacokinetics of ascending doses of MHAA4549A in healthy volunteers. Volunteers will be randomized to receive a single dose of MHAA4549A or matching placebo.

Timeline

Start: 2013-07
Primary completion: 2013-11
Completion: 2013-11

Publications

Lim JJ, Deng R, Derby MA, Larouche R, Horn P, Anderson M, Maia M, Carrier S, Pelletier I, Burgess T, Kulkarni P, Newton E, Tavel JA. 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. Antimicrob Agents Chemother. 2016 Aug 22;60(9):5437-44. doi: 10.1128/AAC.00607-16. Print 2016 Sep.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	GEDIVUMAB	Monoclonal antibody	1.5 mg/kg	Intravenous
Subject	GEDIVUMAB	Monoclonal antibody	5 mg/kg	Intravenous
Subject	GEDIVUMAB	Monoclonal antibody	15 mg/kg	Intravenous
Subject	GEDIVUMAB	Monoclonal antibody	45 mg/kg	Intravenous

Indications

No indication recorded.