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Study to Evaluate the Effect of KB001-A on Time-to-Need for Antibiotic Treatment (KB001-A)

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ClinicalTrials.gov Identifier: NCT01695343
Recruitment Status : Completed
First Posted : September 27, 2012
Last Update Posted : January 14, 2015
Information provided by (Responsible Party):
Humanigen, Inc.

Brief Summary:
The purpose of this study is to confirm and extend the Phase 1-2 KB001 findings of an airway anti-inflammatory effect in CF individuals with chronic Pseudomonas aeruginosa (Pa) airway infection. It is hypothesized that steady-state levels of KB001-A in CF subjects with airway Pa infection will be safe and well-tolerated, and will increase the time-to-need for antibiotic treatment (IV, inhaled, or oral) for worsening of respiratory tract signs and symptoms compared with placebo.

Condition or disease Intervention/treatment Phase
Cystic Fibrosis Biological: KB001-A Drug: Placebo Comparator Phase 2

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 182 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Treatment
Official Title: A Phase 2, Randomized, Double-blind, Placebo-controlled, Repeat-dose Study of KB001-A in Subjects With Cystic Fibrosis Infected With Pseudomonas Aeruginosa
Study Start Date : December 2012
Actual Primary Completion Date : November 2014
Actual Study Completion Date : December 2014

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Cystic Fibrosis

Arm Intervention/treatment
Experimental: KB001-A
KB001-A administered up to 5x intravenously (IV) at 10 mg/kg up to a maximum dose of 800 mg per dose.
Biological: KB001-A
Placebo Comparator: Placebo Comparator
Placebo administered up to 5x intravenously
Drug: Placebo Comparator

Primary Outcome Measures :
  1. To evaluate the effect of KB001-A on time-to-need for antibiotic (ABX) treatment for worsening of respiratory tract signs and symptoms. [ Time Frame: 16 Weeks ]
    Time-to-need for ABX treatment will be the length of time between study material dosing and administration of ABX as needed for worsening respiratory conditions.

Secondary Outcome Measures :
  1. Safety and tolerability of KB001-A [ Time Frame: 16 Weeks ]
    Safety and tolerability will be measured by Adverse Events (AEs) and laboratory assessments

Information from the National Library of Medicine

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Ages Eligible for Study:   12 Years to 50 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • Individuals with CF who are older than 50 years of age may participate if treated with 2 or more courses of antibiotics (IV and/or oral) for respiratory sign and symptoms (CF exacerbation) in the 12 months before the Screening Visit
  • Confirmed diagnosis of CF
  • At least 2 respiratory tract cultures in the previous 12 months, with Pa present. The most recent positive Pa culture must be within 12 weeks before the Screening Visit (or obtain a positive culture at screening)
  • FEV1 % levels within acceptable ranges (per the study protocol)
  • Received inhaled ABX for equivalent of 8 weeks or greater in the 26 weeks before the Day 0 Visit

Exclusion Criteria:

  • Treatment with antibiotics for acute illness within the 4 weeks before the Day 0 Visit
  • Use of systemic corticosteroids within the 4 weeks before the Day 0 Visit
  • Any change in regimen of CF maintenance therapies within the 4 weeks before the Day 0 Visit
  • History of sputum cultures positive for B. cepacia complex in the 2 years before the Screening Visit
  • History of organ transplantation
  • Current smoker (tobacco, marijuana, or any other material). Use of smokeless inhalers/vaporizers for these materials is also prohibited
  • History of drug addiction or alcohol abuse in the 12 months before the Screening Visit
  • History of hepatic disease (clinical cirrhosis or portal hypertension), renal dysfunction
  • Breast-feeding or pregnancy as evidenced by a positive blood pregnancy test
  • Receiving any investigational drug in the 16 weeks (or 5 half lives) before the Day 0 Visit, whichever is longer

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 ClinicalTrials.gov identifier (NCT number): NCT01695343

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Sponsors and Collaborators
Humanigen, Inc.
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Study Chair: Nestor A. Molfino, MD., MSc KaloBios Pharmaceuticals, Inc.
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Responsible Party: Humanigen, Inc.
ClinicalTrials.gov Identifier: NCT01695343    
Other Study ID Numbers: KB001A-05
First Posted: September 27, 2012    Key Record Dates
Last Update Posted: January 14, 2015
Last Verified: January 2015
Keywords provided by Humanigen, Inc.:
Cystic Fibrosis
Pseudomonas aeruginosa (Pa)
Additional relevant MeSH terms:
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Cystic Fibrosis
Pathologic Processes
Pancreatic Diseases
Digestive System Diseases
Lung Diseases
Respiratory Tract Diseases
Genetic Diseases, Inborn
Infant, Newborn, Diseases