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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
KaloBios Pharmaceuticals
ClinicalTrials.gov Identifier:
NCT00638365
First received: March 12, 2008
Last updated: June 4, 2014
Last verified: June 2014
  Purpose

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)


Condition Intervention Phase
Cystic Fibrosis
Biological: KB001
Other: Placebo
Phase 1
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Phase I/II Randomized, Double-Blind, Placebo-Controlled, Single-Dose, Dose Escalation Study of KB001 in Cystic Fibrosis Patients Infected With Pseudomonas Aeruginosa

Resource links provided by NLM:


Further study details as provided by KaloBios Pharmaceuticals:

Primary Outcome Measures:
  • The Safety and Tolerability of a Single-dose of KB001. [ Time Frame: Day 28 ] [ Designated as safety issue: Yes ]
    Safety assessments were conducted after completion of day 28. AEs were followed through completion of day 56.


Enrollment: 27
Study Start Date: March 2008
Study Completion Date: April 2009
Primary Completion Date: March 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1
KB001, a monoclonal antibody
Biological: KB001
Single-dose, 3mg/kg or 10mg/kg dose administered intravenously
Other Name: KB001-recombinant human anti-Pa PcrV Fab antibody
Placebo Comparator: 2
Placebo
Other: Placebo
Placebo single-dose administered intravenously
Other Name: Placebo

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.

  Eligibility

Ages Eligible for Study:   12 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00638365

Locations
United States, Alabama
University of Alabama
Birmingham, Alabama, United States, 35233
United States, California
Lucille Packard Children's Hospital at Stanford
Stanford, California, United States, 94305
United States, Colorado
University of Colorado
Aurora, Colorado, United States, 80045
United States, Maryland
Johns Hopkins University
Baltimore, Maryland, United States, 21287
United States, Minnesota
University of Minnesota
Minneapolis, Minnesota, United States, 55455
United States, Missouri
St. Louis Children's Hospital
St. Louis, Missouri, United States, 63110
United States, Ohio
Cincinnati Children's Hospital Medical Center
Cincinnati, Ohio, United States, 45229
Case Western Reserve University
Cleveland, Ohio, United States, 44106
Nationwide Children's Hospital
Columbus, Ohio, United States, 43205
United States, Pennsylvania
Children's Hospital of Pittsburgh
Pittsburgh, Pennsylvania, United States, 15213
United States, Utah
University of Utah
Salt Lake City, Utah, United States, 84132
Sponsors and Collaborators
KaloBios Pharmaceuticals
Investigators
Principal Investigator: Carlos Milla, MD Stanford University
Study Director: Nestor A. Molfino, MD, MSc KaloBios Pharmaceuticals
  More Information

Additional Information:
No publications provided

Responsible Party: KaloBios Pharmaceuticals
ClinicalTrials.gov Identifier: NCT00638365     History of Changes
Other Study ID Numbers: KB001-03
Study First Received: March 12, 2008
Results First Received: July 12, 2011
Last Updated: June 4, 2014
Health Authority: United States: Food and Drug Administration
United States: Institutional Review Board

Keywords provided by KaloBios Pharmaceuticals:
Cystic Fibrosis, Pseudomonas aeruginosa, Pulmonary CF

Additional relevant MeSH terms:
Cystic Fibrosis
Fibrosis
Pseudomonas Infections
Pancreatic Diseases
Digestive System Diseases
Lung Diseases
Respiratory Tract Diseases
Genetic Diseases, Inborn
Infant, Newborn, Diseases
Pathologic Processes
Gram-Negative Bacterial Infections
Bacterial Infections

ClinicalTrials.gov processed this record on July 20, 2014