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

Primary Purpose

Cystic Fibrosis

Status
Completed
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
KB001
Placebo
Sponsored by
Humanigen, Inc.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Cystic Fibrosis focused on measuring Cystic Fibrosis, Pseudomonas aeruginosa, Pulmonary CF

Eligibility Criteria

12 Years - undefined (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • University of Alabama
  • Lucille Packard Children's Hospital at Stanford
  • University of Colorado
  • Johns Hopkins University
  • University of Minnesota
  • St. Louis Children's Hospital
  • Cincinnati Children's Hospital Medical Center
  • Case Western Reserve University
  • Nationwide Children's Hospital
  • Children's Hospital of Pittsburgh
  • University of Utah

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

1

2

Arm Description

KB001, a monoclonal antibody

Placebo

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Full Information

First Posted
March 12, 2008
Last Updated
June 4, 2014
Sponsor
Humanigen, Inc.
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1. Study Identification

Unique Protocol Identification Number
NCT00638365
Brief Title
Dose Escalation Study of KB001 in Cystic Fibrosis Patients Infected With Pseudomonas Aeruginosa
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 Type
Interventional

2. Study Status

Record Verification Date
June 2014
Overall Recruitment Status
Completed
Study Start Date
March 2008 (undefined)
Primary Completion Date
March 2009 (Actual)
Study Completion Date
April 2009 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Humanigen, Inc.

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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)
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cystic Fibrosis
Keywords
Cystic Fibrosis, Pseudomonas aeruginosa, Pulmonary CF

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1, Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
27 (Actual)

8. Arms, Groups, and Interventions

Arm Title
1
Arm Type
Experimental
Arm Description
KB001, a monoclonal antibody
Arm Title
2
Arm Type
Placebo Comparator
Arm Description
Placebo
Intervention Type
Biological
Intervention Name(s)
KB001
Other Intervention Name(s)
KB001-recombinant human anti-Pa PcrV Fab antibody
Intervention Description
Single-dose, 3mg/kg or 10mg/kg dose administered intravenously
Intervention Type
Other
Intervention Name(s)
Placebo
Intervention Description
Placebo single-dose administered intravenously
Primary Outcome Measure Information:
Title
The Safety and Tolerability of a Single-dose of KB001.
Description
Safety assessments were conducted after completion of day 28. AEs were followed through completion of day 56.
Time Frame
Day 28

10. Eligibility

Sex
All
Minimum Age & Unit of Time
12 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Carlos Milla, MD
Organizational Affiliation
Stanford University
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Nestor A. Molfino, MD, MSc
Organizational Affiliation
Humanigen, Inc.
Official's Role
Study Director
Facility Information:
Facility Name
University of Alabama
City
Birmingham
State/Province
Alabama
ZIP/Postal Code
35233
Country
United States
Facility Name
Lucille Packard Children's Hospital at Stanford
City
Stanford
State/Province
California
ZIP/Postal Code
94305
Country
United States
Facility Name
University of Colorado
City
Aurora
State/Province
Colorado
ZIP/Postal Code
80045
Country
United States
Facility Name
Johns Hopkins University
City
Baltimore
State/Province
Maryland
ZIP/Postal Code
21287
Country
United States
Facility Name
University of Minnesota
City
Minneapolis
State/Province
Minnesota
ZIP/Postal Code
55455
Country
United States
Facility Name
St. Louis Children's Hospital
City
St. Louis
State/Province
Missouri
ZIP/Postal Code
63110
Country
United States
Facility Name
Cincinnati Children's Hospital Medical Center
City
Cincinnati
State/Province
Ohio
ZIP/Postal Code
45229
Country
United States
Facility Name
Case Western Reserve University
City
Cleveland
State/Province
Ohio
ZIP/Postal Code
44106
Country
United States
Facility Name
Nationwide Children's Hospital
City
Columbus
State/Province
Ohio
ZIP/Postal Code
43205
Country
United States
Facility Name
Children's Hospital of Pittsburgh
City
Pittsburgh
State/Province
Pennsylvania
ZIP/Postal Code
15213
Country
United States
Facility Name
University of Utah
City
Salt Lake City
State/Province
Utah
ZIP/Postal Code
84132
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
24019259
Citation
Milla CE, Chmiel JF, Accurso FJ, VanDevanter DR, Konstan MW, Yarranton G, Geller DE; KB001 Study Group. Anti-PcrV antibody in cystic fibrosis: a novel approach targeting Pseudomonas aeruginosa airway infection. Pediatr Pulmonol. 2014 Jul;49(7):650-8. doi: 10.1002/ppul.22890. Epub 2013 Sep 9.
Results Reference
derived
Links:
URL
http://www.cff.org
Description
Cystic Fibrosis Foundation

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

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