Research

Dose Escalation Study of KB001 in Cystic Fibrosis Patients

Single-Dose, Dose Escalation Study of KB001 in Cystic Fibrosis Patients Infected with Pseudomonas aeruginosa

Protocol Description

This Phase I/II multi-center research study involves a one-time infusion of the study medication, KB001, into a vein for the treatment of Pseudomonas aeruginosa bacteria in cystic fibrosis patients. Pseudomonas aeruginosa may infect the airways of people who have cystic fibrosis. KB001 is an antibody that may hinder the ability of the bacteria to damage immune cells.

Eligibility Criteria

The study is currently accepting both males and females, ages 12 years and older, who have cystic fibrosis and have been infected with Pseudomonas aeruginosa.
Males: 12 years of age and older
Females: 12 years of age and older

Requirements
In addition to the screening visit and initial testing, participants will be randomly assigned to receive a single infusion of either a placebo or the study drug. Infusions take about 1 hour to administer, with patient observation lasting another 4 hours. Return visits to the Pediatric Clinical and Translational Research Center are required for follow up procedures.
Visits: 5
Duration: 10 weeks

Status: Open for Enrollment

Source of Support
KaloBios Pharmaceuticals, Inc.

Additional Resources
Study description at National Institutes of Health