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

June 4, 2014 updated by: Humanigen, Inc.

A Phase I/II Randomized, Double-Blind, Placebo-Controlled, Single-Dose, Dose Escalation Study of KB001 in Cystic Fibrosis Patients Infected With Pseudomonas Aeruginosa

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)

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

27

Phase

  • Phase 2
  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Alabama
      • Birmingham, Alabama, United States, 35233
        • University of Alabama
    • California
      • Stanford, California, United States, 94305
        • Lucille Packard Children's Hospital at Stanford
    • Colorado
      • Aurora, Colorado, United States, 80045
        • University of Colorado
    • Maryland
      • Baltimore, Maryland, United States, 21287
        • Johns Hopkins University
    • Minnesota
      • Minneapolis, Minnesota, United States, 55455
        • University of Minnesota
    • Missouri
      • St. Louis, Missouri, United States, 63110
        • St. Louis Children's Hospital
    • Ohio
      • Cincinnati, Ohio, United States, 45229
        • Cincinnati Children's Hospital Medical Center
      • Cleveland, Ohio, United States, 44106
        • Case Western Reserve University
      • Columbus, Ohio, United States, 43205
        • Nationwide Children's Hospital
    • Pennsylvania
      • Pittsburgh, Pennsylvania, United States, 15213
        • Children's Hospital of Pittsburgh
    • Utah
      • Salt Lake City, Utah, United States, 84132
        • University of Utah

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

12 years and older (ADULT, OLDER_ADULT, CHILD)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: TRIPLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
PLACEBO_COMPARATOR: 2
Placebo
Other: Placebo
Placebo single-dose administered intravenously
EXPERIMENTAL: 1
KB001, a monoclonal antibody
Biological: KB001
Single-dose, 3mg/kg or 10mg/kg dose administered intravenously
Other Names:
  • KB001-recombinant human anti-Pa PcrV Fab antibody

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Day 28

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Humanigen, Inc.

Investigators

  • Study Director: Nestor A. Molfino, MD, MSc, Humanigen, Inc.

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

March 1, 2008

Primary Completion (ACTUAL)

March 1, 2009

Study Completion (ACTUAL)

April 1, 2009

Study Registration Dates

First Submitted

March 12, 2008

First Submitted That Met QC Criteria

March 12, 2008

First Posted (ESTIMATE)

March 19, 2008

Study Record Updates

Last Update Posted (ESTIMATE)

June 9, 2014

Last Update Submitted That Met QC Criteria

June 4, 2014

Last Verified

June 1, 2014

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • KB001-03

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Cystic Fibrosis

Clinical Trials on KB001

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Madagascar

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe