A Study to Investigate the Safety, Tolerability, and Pharmacokinetics of MHAB5553A in Healthy Volunteers

Phase 1 Completed 26 enrolled Genentech, Inc.

RandomizedSingle-groupDouble-blindBasic science

Summary

This is a Phase 1, randomized, double-blind, placebo-controlled, single-ascending dose study in healthy volunteers to investigate the safety, tolerability, and pharmacokinetics (PK) of MHAB5553A.

Timeline

Start: 2015-08-18
Primary completion: 2016-01-26
Completion: 2016-01-26

Publications

Lim JJ, Derby MA, Zhang Y, Deng R, Larouche R, Anderson M, Maia M, Carrier S, Pelletier I, Girard J, Kulkarni P, Newton E, Tavel JA. A Phase 1, Randomized, Double-Blind, Placebo-Controlled, Single-Ascending-Dose Study To Investigate the Safety, Tolerability, and Pharmacokinetics of an Anti-Influenza B Virus Monoclonal Antibody, MHAB5553A, in Healthy Volunteers. Antimicrob Agents Chemother. 2017 Jul 25;61(8):e00279-17. doi: 10.1128/AAC.00279-17. Print 2017 Aug.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	LESOFAVUMAB	Monoclonal antibody	120 mg	Intravenous
Subject	LESOFAVUMAB	Monoclonal antibody	1200 mg	Intravenous
Subject	LESOFAVUMAB	Monoclonal antibody	3600 mg	Intravenous
Subject	LESOFAVUMAB	Monoclonal antibody	8400 mg	Intravenous
Subject	LESOFAVUMAB	Monoclonal antibody	10800 mg	Intravenous

Indications

No indication recorded.