A Study of RG7667 in Healthy Volunteers

Phase 1 Completed 170 enrolled Genentech, Inc.

RandomizedParallel-groupDouble-blind

Summary

This randomized, double-blind, placebo-controlled study will evaluate the safety and pharmacokinetics of RG7667 in healthy volunteers. Subjects will be randomized in cohorts to receive either single/multiple doses of RG7667 intravenously or placebo. Anticipated time on study treatment is up to 57 days with a 12-week follow-up.

Timeline

Start: 2012-01
Primary completion: 2013-01
Completion: 2013-01

Publications

Ishida JH, Burgess T, Derby MA, Brown PA, Maia M, Deng R, Emu B, Feierbach B, Fouts AE, Liao XC, Tavel JA. Phase 1 Randomized, Double-Blind, Placebo-Controlled Study of RG7667, an Anticytomegalovirus Combination Monoclonal Antibody Therapy, in Healthy Adults. Antimicrob Agents Chemother. 2015 Aug;59(8):4919-29. doi: 10.1128/AAC.00523-15. Epub 2015 Jun 8.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	RG7667	Monoclonal antibody	1 mg/kg	Intravenous
Subject	RG7667	Monoclonal antibody	3 mg/kg	Intravenous
Subject	RG7667	Monoclonal antibody	5 mg/kg	Intravenous
Subject	RG7667	Monoclonal antibody	10 mg/kg	Intravenous

Indications

No indication recorded.