A Phase 1, Open Label, Dose-escalation Study of the Safety, Pharmacokinetics and Antiretroviral Activity of 3BNC117

NCT02018510 ↗

Phase 1 Completed 49 enrolled Rockefeller University Brigham and Women's Hospital · collab University of Cologne · collab Weill Medical College of Cornell University · collab

Non-randomizedParallel-groupOpen-labelPrevention

Summary

The proposed study is a first-in-man phase I study that aims to evaluate the safety, tolerability and pharmacokinetics of 3BNC117 in HIV-infected and HIV-uninfected subjects, and its antiretroviral activity in HIV-infected subjects.

Timeline

Start: 2014-01
Primary completion: 2016-01
Completion: 2016-01

Publications

Schoofs T, Klein F, Braunschweig M, Kreider EF, Feldmann A, Nogueira L, Oliveira T, Lorenzi JC, Parrish EH, Learn GH, West AP Jr, Bjorkman PJ, Schlesinger SJ, Seaman MS, Czartoski J, McElrath MJ, Pfeifer N, Hahn BH, Caskey M, Nussenzweig MC. HIV-1 therapy with monoclonal antibody 3BNC117 elicits host immune responses against HIV-1. Science. 2016 May 20;352(6288):997-1001. doi: 10.1126/science.aaf0972. Epub 2016 May 5.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	LAFUVITUG	Monoclonal antibody	1 mg/kg	Intravenous
Subject	LAFUVITUG	Monoclonal antibody	3 mg/kg	Intravenous
Subject	LAFUVITUG	Monoclonal antibody	10 mg/kg	Intravenous
Subject	LAFUVITUG	Monoclonal antibody	30 mg/kg	Intravenous

A Phase 1, Open Label, Dose-escalation Study of the Safety, Pharmacokinetics and Antiretroviral Activity of 3BNC117

Summary

Timeline

Publications

Drugs

Indications