Study of Safety, Tolerability, and Pharmacokinetics of REGN3470-3471-3479 in Healthy Adult Volunteers

Phase 1 Completed 24 enrolled Regeneron Pharmaceuticals Department of Health and Human Services · collab

RandomizedParallel-groupTriple-blindBasic science

Summary

This is a Phase 1, randomized, double-blind, placebo-controlled, dose escalation study evaluating the safety, tolerability, pharmacokinetics (PK) and immunogenicity of REGN3470-3471-3479 in healthy adult volunteers.

Timeline

Start: 2016-05-27
Primary completion: 2017-04-26
Completion: 2017-04-26

Publications

Sivapalasingam S, Kamal M, Slim R, Hosain R, Shao W, Stoltz R, Yen J, Pologe LG, Cao Y, Partridge M, Sumner G, Lipsich L. Safety, pharmacokinetics, and immunogenicity of a co-formulated cocktail of three human monoclonal antibodies targeting Ebola virus glycoprotein in healthy adults: a randomised, first-in-human phase 1 study. Lancet Infect Dis. 2018 Aug;18(8):884-893. doi: 10.1016/S1473-3099(18)30397-9. Epub 2018 Jun 18.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Inmazeb	Monoclonal antibody	3 mg/kg	Intravenous
Subject	Inmazeb	Monoclonal antibody	15 mg/kg	Intravenous
Subject	Inmazeb	Monoclonal antibody	60 mg/kg	Intravenous
Subject	Inmazeb	Monoclonal antibody	150 mg/kg	Intravenous

Indications

No indication recorded.