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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00638365
Recruitment Status : Completed
First Posted : March 19, 2008
Results First Posted : August 8, 2011
Last Update Posted : June 9, 2014
Information provided by (Responsible Party):
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)

Condition or disease Intervention/treatment Phase
Cystic Fibrosis Biological: KB001 Other: Placebo Phase 1 Phase 2

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 27 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, 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
Study Start Date : March 2008
Actual Primary Completion Date : March 2009
Actual Study Completion Date : April 2009

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Cystic Fibrosis

Arm Intervention/treatment
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
Other: Placebo
Placebo single-dose administered intravenously

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

Information from the National Library of Medicine

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Ages Eligible for Study:   12 Years and older   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00638365

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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
Humanigen, Inc.
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Principal Investigator: Carlos Milla, MD Stanford University
Study Director: Nestor A. Molfino, MD, MSc Humanigen, Inc.
Additional Information:
Publications automatically indexed to this study by Identifier (NCT Number):
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Responsible Party: Humanigen, Inc. Identifier: NCT00638365    
Other Study ID Numbers: KB001-03
First Posted: March 19, 2008    Key Record Dates
Results First Posted: August 8, 2011
Last Update Posted: June 9, 2014
Last Verified: June 2014
Keywords provided by Humanigen, Inc.:
Cystic Fibrosis, Pseudomonas aeruginosa, Pulmonary CF
Additional relevant MeSH terms:
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Pseudomonas Infections
Cystic Fibrosis
Pathologic Processes
Pancreatic Diseases
Digestive System Diseases
Lung Diseases
Respiratory Tract Diseases
Genetic Diseases, Inborn
Infant, Newborn, Diseases
Gram-Negative Bacterial Infections
Bacterial Infections