Dose Escalation Study of KB001 in Cystic Fibrosis Patients Infected With Pseudomonas Aeruginosa - Full Text View

Sponsored by:	KaloBios Pharmaceuticals
Information provided by:	KaloBios Pharmaceuticals
ClinicalTrials.gov Identifier:	NCT00638365

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 I Phase II

Genetics Home Reference related topics: cystic fibrosis

MedlinePlus related topics: Cystic Fibrosis

Drug Information available for: Immunoglobulins Globulin, Immune

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double Blind (Subject, Investigator, Outcomes Assessor), Parallel Assignment, Safety Study
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

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 ]

Secondary Outcome Measures:

To measure to the pharmacodynamic effects of a single-dose of KB001 as determined by lung microbial ecology and lung function. [ Time Frame: Day 28 ] [ Designated as safety issue: Yes ]

Estimated Enrollment:	48
Study Start Date:	March 2008
Estimated Study Completion Date:	June 2009
Estimated Primary Completion Date:	March 2009 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1: Experimental KB001, a monoclonal antibody	Biological: KB001 Single-dose, 3mg/kg or 10mg/kg dose administered intravenously
2: Placebo Comparator Placebo	Other: Placebo Placebo single-dose administered intravenously

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

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

Contacts

Contact: Thomas Tremblay, RN

650-843-1897 ext 332

ttremblay@kalobios.com

Locations

United States, Alabama
University of Alabama	Recruiting
Birmingham, Alabama, United States, 35233
Principal Investigator: John Clancy, MD
United States, California
Lucille Packard Children's Hospital at Stanford	Recruiting
Stanford, California, United States, 94305
Principal Investigator: Carlos Milla, MD
United States, Colorado
University of Colorado	Recruiting
Aurora, Colorado, United States, 80045
Principal Investigator: Frank Accurso, MD
United States, Maryland
Johns Hopkins University	Recruiting
Baltimore, Maryland, United States, 21287
Principal Investigator: Michael Boyle, MD
United States, Minnesota
University of Minnesota	Recruiting
Minneapolis, Minnesota, United States, 55455
Principal Investigator: Joanne Billings, MD
United States, Missouri
St. Louis Children's Hospital	Recruiting
St. Louis, Missouri, United States, 63110
Principal Investigator: Jeff Atkinson, MD
United States, Ohio
Nationwide Children's Hospital	Recruiting
Columbus, Ohio, United States, 43205
Principal Investigator: Karen McCoy, MD
Case Western Reserve University	Recruiting
Cleveland, Ohio, United States, 44106
Principal Investigator: James Chmiel, MD
Cincinnati Children's Hospital Medical Center	Recruiting
Cincinnati, Ohio, United States, 45229
Principal Investigator: James Acton, MD
United States, Pennsylvania
Children's Hospital of Pittsburgh	Recruiting
Pittsburgh, Pennsylvania, United States, 15213
Principal Investigator: Joseph Pilewski, MD
United States, Utah
University of Utah	Recruiting
Salt Lake City, Utah, United States, 84132
Principal Investigator: Ted Liou, MD

Sponsors and Collaborators

KaloBios Pharmaceuticals

Investigators

Principal Investigator:	Carlos Milla, MD	Stanford University
Study Director:	Tillman Pearce, MD	KaloBios Pharmaceuticals

More Information

Cystic Fibrosis Foundation This link exits the ClinicalTrials.gov site

Responsible Party:	KaloBios Pharmaceuticals ( Tillman Pearce, MD )
Study ID Numbers:	KB001-03
Study First Received:	March 12, 2008
Last Updated:	January 6, 2009
ClinicalTrials.gov Identifier:	NCT00638365
Health Authority:	United States: Food and Drug Administration; United States: Institutional Review Board

Keywords provided by KaloBios Pharmaceuticals:

Cystic Fibrosis, Pseudomonas aeruginosa, Pulmonary CF

Study placed in the following topic categories:

Antibodies
Digestive System Diseases
Genetic Diseases, Inborn
Respiratory Tract Diseases
Cystic Fibrosis
Fibrosis

Lung Diseases
Infant, Newborn, Diseases
Pancreatic Diseases
Cystic fibrosis
Immunoglobulins

Additional relevant MeSH terms:

Pathologic Processes

ClinicalTrials.gov processed this record on January 16, 2009