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

Phase 1

Completed

• Conditions: Cystic Fibrosis
• Interventions: Biological: KB001; Other: Placebo

• Registration Number: NCT00638365
• Lead Sponsor: Humanigen, Inc.

Brief 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.

Study Timeline

• Study Start: 2008-03
• Study First Submitted: 2008-03-12
• Study First Submitted QC: 2008-03-12
• Study First Posted: 2008-03-19
• Primary Completion: 2009-03
• Study Completion: 2009-04
• Results First Submitted: 2011-07-12
• Results First Submitted QC: 2011-07-12
• Results First Posted: 2011-08-08
• Status Verified: 2014-06
• Last Update Submitted: 2014-06-04
• Last Update Posted: 2014-06-09

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 27

Inclusion Criteria

• Written informed consent
• Confirmed diagnosis of CF based on the following criteria:

Positive sweat chloride greater than 60mEq/liter, and/or a genotype with 2 identifiable mutations consistent with CF, and one or more clinical features consistent with the CF phenotype

• Age >/= 18 years of age with the potential for age 12 >/=
• Screening Pa sputum culture
• FEV1% predicted >/= 40 (based on Wang's equations for Males aged 12-17 and females 12-15 years, and Hankinson's equations for all other patients)

Exclusion Criteria

• Evidence of an acute respiratory infection or pulmonary exacerbation within 4 weeks prior to day 0
• Use of systemic corticosteroids or antibiotics within 4 weeks prior to day 0, or cyclic inhaled antibiotics within 14 days prior to day 0.
• History of positive B. cepacia complex, organ transplantation, hepatic disease or venal dysfunction
• Current cigarette smoker, history of drug addiction or alcohol abuse
• Use of investigational medication or participation in an investigational study within 4 weeks prior to day 0
• Women who are pregnant or breastfeeding and patients and/or partner unwilling to use an effective form of barrier contraception throughout the study

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
1	KB001	KB001, a monoclonal antibody
2	Placebo	Placebo

Primary Outcome Measures

Name	Time	Method
The Safety and Tolerability of a Single-dose of KB001.	Day 28	Safety assessments were conducted after completion of day 28. AEs were followed through completion of day 56.

Trial Locations

Locations (11)

Johns Hopkins University; 🇺🇸 Baltimore, Maryland, United States

University of Utah; 🇺🇸 Salt Lake City, Utah, United States

University of Minnesota; 🇺🇸 Minneapolis, Minnesota, United States

Nationwide Children's Hospital; 🇺🇸 Columbus, Ohio, United States

University of Alabama; 🇺🇸 Birmingham, Alabama, United States

St. Louis Children's Hospital; 🇺🇸 St. Louis, Missouri, United States

Lucille Packard Children's Hospital at Stanford; 🇺🇸 Stanford, California, United States

Cincinnati Children's Hospital Medical Center; 🇺🇸 Cincinnati, Ohio, United States

Case Western Reserve University; 🇺🇸 Cleveland, Ohio, United States

Children's Hospital of Pittsburgh; 🇺🇸 Pittsburgh, Pennsylvania, United States

University of Colorado; 🇺🇸 Aurora, Colorado, United States