A Study of CNTO 3157 in Healthy Normal and Asthmatic Participants Inoculated With Human Rhinovirus Type 16

Phase 1 Completed 76 enrolled Janssen Research & Development, LLC

RandomizedParallel-groupDouble-blindBasic science

Summary

The main purposes of this study are to evaluate the safety (Parts 1 and 2) and efficacy (Part 2) of pretreatment with CNTO 3157 in healthy adult and asthmatic adult participants before and after intranasal (into the nose) inoculation with human rhinovirus type 16 (HRV-16).

Timeline

Start: 2012-10
Primary completion: 2014-11
Completion: 2014-11

Outcome

Missed primary endpoint

paper In asthmatic patients (n = 63) CNTO3157 provided no protection against FEV1 decrease PMID 28734844 ↗

Publications

Silkoff PE, Flavin S, Gordon R, Loza MJ, Sterk PJ, Lutter R, Diamant Z, Turner RB, Lipworth BJ, Proud D, Singh D, Eich A, Backer V, Gern JE, Herzmann C, Halperin SA, Mensinga TT, Del Vecchio AM, Branigan P, San Mateo L, Baribaud F, Barnathan ES, Johnston SL. Toll-like receptor 3 blockade in rhinovirus-induced experimental asthma exacerbations: A randomized controlled study. J Allergy Clin Immunol. 2018 Apr;141(4):1220-1230. doi: 10.1016/j.jaci.2017.06.027. Epub 2017 Jul 20.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	CNTO 3157	Monoclonal antibody	3 mg/kg	Intravenous
Subject	CNTO 3157	Monoclonal antibody	10 mg/kg	Intravenous

Indications

No indication recorded.