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

Cystic Fibrosis Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00638365
• Other study ID #: KB001-03
• Status: Completed
• Phase: Phase 1/Phase 2
• First received: March 12, 2008
• Last updated: June 4, 2014
• Start date: March 2008
• Est. completion date: April 2009

Study information

• Verified date: June 2014
• Source: KaloBios Pharmaceuticals
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug AdministrationUnited States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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)

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 27
• Est. completion date: April 2009
• Est. primary completion date: March 2009
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 12 Years and older

Eligibility

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

Allocation: Randomized, Endpoint Classification: Safety Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Cystic Fibrosis
• Fibrosis
• Pseudomonas Infections

Intervention

Biological:
• KB001
Single-dose, 3mg/kg or 10mg/kg dose administered intravenously

Other:
• Placebo
Placebo single-dose administered intravenously

Locations

Country	Name	City	State
United States	University of Colorado	Aurora	Colorado
United States	Johns Hopkins University	Baltimore	Maryland
United States	University of Alabama	Birmingham	Alabama
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	University of Minnesota	Minneapolis	Minnesota
United States	Children's Hospital of Pittsburgh	Pittsburgh	Pennsylvania
United States	University of Utah	Salt Lake City	Utah
United States	St. Louis Children's Hospital	St. Louis	Missouri
United States	Lucille Packard Children's Hospital at Stanford	Stanford	California

Sponsors (1)

Lead Sponsor	Collaborator
KaloBios Pharmaceuticals

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The Safety and Tolerability of a Single-dose of KB001.	Safety assessments were conducted after completion of day 28. AEs were followed through completion of day 56.	Day 28	Yes

External Links

•   Cystic Fibrosis Foundation