NCT00638365

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

A Phase I/II Randomized, Double-Blind, Placebo-Controlled, Single-Dose, Dose Escalation Study of KB001 in Cystic Fibrosis Patients Infected With Pseudomonas Aeruginosa

• Status: Completed
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 27 (actual)
• Sponsor: Humanigen, Inc. · Industry
• Sex: All
• Age: 12 Years
• Healthy volunteers: Not accepted

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)

Detailed description

CF patients often have lung infections. Pseudomonas aeruginosa (Pa) is the most significant bacteria in CF, with up to 80% of CF patients eventually becoming infected. These patients are often treated with antibiotics with variable results. This study will examine the impact of a single-dose of an investigational drug, KB001, on Pa bacteria in the CF lung.

Conditions

• Cystic Fibrosis

Interventions

Type	Name	Description
BIOLOGICAL	KB001	Single-dose, 3mg/kg or 10mg/kg dose administered intravenously
OTHER	Placebo	Placebo single-dose administered intravenously

Timeline

• Start date: 2008-03-01
• Primary completion: 2009-03-01
• Completion: 2009-04-01
• First posted: 2008-03-19
• Last updated: 2014-06-09
• Results posted: 2011-08-08

Locations

11 sites across 1 country: United States