A Study Evaluating Intravenous and Subcutaneous Administration of a Human Monoclonal Antibody (CNTO 5825) in Healthy Volunteers

Phase 1 Completed 64 enrolled Centocor, Inc.

RandomizedSingle-groupTriple-blindTreatment

Summary

The purpose of this study is to assess the safety and tolerability of CNTO 5825 following a single intravenous (IV) or subcutaneous (SC) dose administration in healthy volunteers.

Timeline

Start: 2010-02
Primary completion: —
Completion: 2010-09

Publications

van Hartingsveldt B, Nnane IP, Bouman-Thio E, Loza MJ, Piantone A, Davis HM, Petty KJ. Safety, tolerability and pharmacokinetics of a human anti-interleukin-13 monoclonal antibody (CNTO 5825) in an ascending single-dose first-in-human study. Br J Clin Pharmacol. 2013 May;75(5):1289-98. doi: 10.1111/j.1365-2125.2012.04477.x.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	CNTO 5825	Monoclonal antibody	0.1 mg/kg	Intravenous
Subject	CNTO 5825	Monoclonal antibody	0.3 mg/kg	Intravenous
Subject	CNTO 5825	Monoclonal antibody	1 mg/kg	Intravenous
Subject	CNTO 5825	Monoclonal antibody	3 mg/kg	Intravenous
Subject	CNTO 5825	Monoclonal antibody	10 mg/kg	Intravenous

Indications

No indication recorded.