NCT01695343

Study to Evaluate the Effect of KB001-A on Time-to-Need for Antibiotic Treatment

A Phase 2, Randomized, Double-blind, Placebo-controlled, Repeat-dose Study of KB001-A in Subjects With Cystic Fibrosis Infected With Pseudomonas Aeruginosa

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 182 (actual)
• Sponsor: Humanigen, Inc. · Industry
• Sex: All
• Age: 12 Years – 50 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this study is to confirm and extend the Phase 1-2 KB001 findings of an airway anti-inflammatory effect in CF individuals with chronic Pseudomonas aeruginosa (Pa) airway infection. It is hypothesized that steady-state levels of KB001-A in CF subjects with airway Pa infection will be safe and well-tolerated, and will increase the time-to-need for antibiotic treatment (IV, inhaled, or oral) for worsening of respiratory tract signs and symptoms compared with placebo.

Conditions

• Cystic Fibrosis

Interventions

Type	Name	Description
BIOLOGICAL	KB001-A
DRUG	Placebo Comparator

Timeline

• Start date: 2012-12-01
• Primary completion: 2014-11-01
• Completion: 2014-12-01
• First posted: 2012-09-27
• Last updated: 2015-01-14

Locations

67 sites across 4 countries: United States, Australia, Israel, New Zealand