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

Completed · Phase 1/Phase 2 · Has a placebo group

Conditions studied: Cystic Fibrosis

In brief

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)

Key facts

Study ID

NCT00638365

Run by

Humanigen, Inc.

People needed

27

Starts

2008-03-01

Expected to finish

2009-04-01

Last updated by the study team

2014-06-09

Who can join

Age: 12 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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)

You may not qualify if…

• 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

Where it is running

• University of Alabama — Birmingham, Alabama, United States
• Lucille Packard Children's Hospital at Stanford — Stanford, California, United States
• University of Colorado — Aurora, Colorado, United States
• Johns Hopkins University — Baltimore, Maryland, United States
• University of Minnesota — Minneapolis, Minnesota, United States
• St. Louis Children's Hospital — St Louis, Missouri, United States
• Cincinnati Children's Hospital Medical Center — Cincinnati, Ohio, United States
• Case Western Reserve University — Cleveland, Ohio, United States
• Nationwide Children's Hospital — Columbus, Ohio, United States
• Children's Hospital of Pittsburgh — Pittsburgh, Pennsylvania, United States
• University of Utah — Salt Lake City, Utah, United States

Full record on ClinicalTrials.gov

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