Dose Escalation Study of KB001 in Cystic Fibrosis Patients Infected With Pseudomonas Aeruginosa

Phase 1/2 Completed 27 enrolled Humanigen, Inc.

RandomizedParallel-groupTriple-blindTreatment

Summary

The primary objective of this study is to evaluate the safety and tolerability of a single dose of KB001 in Cystic Fibrosis patients infected with Pseudomonas aeruginosa (Pa)

Timeline

Start: 2008-03
Primary completion: 2009-03
Completion: 2009-04

Publications

Milla CE, Chmiel JF, Accurso FJ, VanDevanter DR, Konstan MW, Yarranton G, Geller DE; KB001 Study Group. Anti-PcrV antibody in cystic fibrosis: a novel approach targeting Pseudomonas aeruginosa airway infection. Pediatr Pulmonol. 2014 Jul;49(7):650-8. doi: 10.1002/ppul.22890. Epub 2013 Sep 9.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	KB001	Monoclonal antibody	3 mg/kg	Intravenous
Subject	KB001	Monoclonal antibody	10 mg/kg	Intravenous

Dose Escalation Study of KB001 in Cystic Fibrosis Patients Infected With Pseudomonas Aeruginosa

Summary

Timeline

Publications

Drugs

Indications