A Study of High Dose MHAA4549A in Healthy Volunteers

Phase 1 Completed 14 enrolled Genentech, Inc.

RandomizedParallel-groupDouble-blindOther

Summary

This Phase 1, randomized, double-blind, placebo-controlled study will evaluate the safety, tolerability and pharmacokinetics of two, single intravenous (IV) high doses of MHAA4549A as compared to placebo when administered to healthy volunteers.

Timeline

Start: 2014-11-03
Primary completion: 2015-03-13
Completion: 2015-03-13

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	8400 mg	Intravenous
Subject	GEDIVUMAB	Monoclonal antibody	10800 mg	Intravenous

Indications

No indication recorded.