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CompletedNCT01695343KB001-AUpdated Jan 14, 2015

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

A Phase 2 interventional study of KB001-A and Placebo Comparator in Cystic Fibrosis, sponsored by Humanigen, Inc.. Completed at 67 sites in 4 countries. Open to participants aged 12 Years to 50 Years. Per ClinicalTrials.gov, last updated 2015-01-14.

Sponsored by Humanigen, Inc. · Phase 2, Interventional, and Treatment

Phase
Phase 2
Study type
Interventional
Enrollment
182
Allocation
Randomized
Ages
12 Years to 50 Years
Sex
All
01

Study 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.

02

Conditions studied

  • Cystic Fibrosis

Keywords

  • Cystic Fibrosis
  • Pseudomonas aeruginosa (Pa)
  • CF
03

In context

Cystic Fibrosis

1,581 studies on the registry are indexed under Cystic Fibrosis; 190 are open to participants now.

This study's enrollment of 182 is above the median of 36 across 1,034 interventional studies indexed under Cystic Fibrosis.

Browse Cystic Fibrosis studies →

Lead sponsor

Humanigen, Inc. is the lead sponsor of 7 studies on the registry; none are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
12 Years to 50 Years
Sexes eligible
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

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
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Study design

Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Triple (Participant, Care provider, Investigator)
Enrollment
182 participants (actual)

Study arms

  • 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

Interventions

  • BiologicalKB001-A
  • DrugPlacebo Comparator
06

What researchers measure

Primary outcomes

  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-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.

    Time frame: 16 Weeks

Secondary outcomes

  1. Safety and tolerability of KB001-A

    Safety and tolerability will be measured by Adverse Events (AEs) and laboratory assessments

    Time frame: 16 Weeks

07

Study locations

67 sites
  • Mobile, Alabama 36608, United States
  • Phoenix, Arizona 85016, United States
  • Tucson, Arizona 85724, United States
  • Little Rock, Arkansas 72205, United States
  • Long Beach, California 90806, United States
  • Oakland, California 94611, United States
  • Orange, California 92868, United States
  • Stanford, California 94304, United States
  • Aurora, Colorado 80045, United States
  • Gainesville, Florida 32610, United States
  • Miami, Florida 33136, United States
  • Orlando, Florida 32806, United States
  • Tampa, Florida 33606, United States
  • Atlanta, Georgia 30322, United States
  • Boise, Idaho 83712, United States
  • Glenview, Illinois 60025, United States
  • Indianapolis, Indiana 46202, United States
  • Iowa City, Iowa 52242, United States
  • Lexington, Kentucky 40536, United States
  • Louisville, Kentucky 40202, United States
  • Portland, Maine 04102, United States
  • Boston, Massachusetts 02115, United States
  • Worchester, Massachusetts 10655, United States
  • Detriot, Michigan 48201, United States
  • Grand Rapids, Michigan 49503, United States
  • Minneapolis, Minnesota 55455, United States
  • Kansas City, Missouri 64108, United States
  • St. Louis, Missouri 63104, United States
  • St. Louis, Missouri 63110, United States
  • Hanover, New Hampshire 03756, United States
  • Manchester, New Hampshire 03756, United States
  • Albuquerque, New Mexico 87131, United States
  • Albany, New York 12208, United States
  • Hawthorne, New York 10532, United States
  • New Hyde Park, New York 11040, United States
  • New York, New York 10032, United States
  • Cincinnati, Ohio 45229, United States
  • Cincinnati, Ohio 45267, United States
  • Cleveland, Ohio 44106, United States
  • Columbus, Ohio 43205, United States
  • Dayton, Ohio 45404, United States
  • Toledo, Ohio 43606, United States
  • Oklahoma City, Oklahoma 73104, United States
  • Hershey, Pennsylvania 17033, United States
  • Philadelphia, Pennsylvania 19102, United States
  • Philadelphia, Pennsylvania 19104, United States
  • Pittsburgh, Pennsylvania 15224, United States
  • Charleston, South Carolina 29425, United States
  • Knoxville, Tennessee 37916, United States
  • Memphis, Tennessee 38105, United States
  • Nashville, Tennessee 37232, United States
  • Austin, Texas 78723, United States
  • Dallas, Texas 75390, United States
  • San Antonio, Texas 78212, United States
  • Colchester, Vermont 05446, United States
  • Richmond, Virginia 23219, United States
  • Madison, Wisconsin 53792, United States
  • Milwaukee, Wisconsin 53226, United States
  • New Lambton, New South Wales 2305, Australia
  • Parkville, Victoria 3052, Australia
  • Nedlands, Western Australia 6009, Australia
  • Haifa, 31096, Israel
  • Jerusalem, 91240, Israel
  • Petah-Tikva, 49202, Israel
  • Tel Hashomer, 52621, Israel
  • Dunedin, 9016, New Zealand
  • Hamilton, 3420, New Zealand
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jan 14, 2015, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT01695343
Lead sponsor
Humanigen, Inc.
Responsible party
Sponsor
First posted
Sep 27, 2012
Start date
Dec 2012
Primary completion
Nov 2014
Completion
Dec 2014
Last update
Jan 14, 2015

Study contacts

Nestor A. Molfino, MD., MSc
study chair · KaloBios Pharmaceuticals, Inc.

Oversight

Data monitoring committee
Yes
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Jan 2015. You cannot join it, but the record below documents what was studied.

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