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CompletedNCT00691587Updated Jul 31, 2009

Pilot Trial of KB001 in Mechanically-Ventilated Patients Colonized With Pseudomonas Aeruginosa

A Phase 1/2 interventional study of KB001 and KB001 in Pseudomonas Aeruginosa and Ventilator Associated Pneumonia, sponsored by Humanigen, Inc.. Completed at 1 site in France. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2009-07-31.

Sponsored by Humanigen, Inc. · Phase 1/2, Interventional, and Prevention

Phase
Phase 1/2
Study type
Interventional
Enrollment
36
Allocation
Randomized
Ages
18 Years and older
Sex
All
01

Study summary

Pseudomonas aeruginosa is an opportunistic pathogen that rarely causes disease in healthy people, but is a significant problem for critically ill or immunocompromised individuals. Experts estimate that there are greater than 100,000 patients in the United States, Europe and Japan where Pseudomonas pneumonia occurs. Patients with Pseudomonas pneumonia currently represent only about 20% of the patients in the hospital who get Pseudomonas infections.

Read the detailed description

This trial will evaluate KB001 in patients in the intensive care setting who are receiving ventilator therapy and who have Pseudomonas infections. They will receive either placebo, or one of two dose levels of KB001, a Humaneered™, high-affinity antibody fragment that KaloBios is developing for the treatment of Pseudomonas aeruginosa (Pa) infections. This trial will evaluate the ability of KB001 to protect host epithelium and immune cells, and evaluate reduction of pulmonary Pa burden.

02

Conditions studied

  • Pseudomonas Aeruginosa
  • Ventilator Associated Pneumonia

Keywords

  • mechanical ventilation
  • mechanically ventilated
  • Pseudomonas aeruginosa
  • ventilator associated pneumonia
03

In context

Pseudomonas Infections

98 studies on the registry are indexed under Pseudomonas Infections; 23 are open to participants now.

This study's planned enrollment of 36 is below the median of 52 across 61 interventional studies indexed under Pseudomonas Infections.

Browse Pseudomonas Infections studies →

Lead sponsor

Humanigen, Inc. is the lead sponsor of 8 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
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • Provision of written informed consent obtained from patient or patient's surrogate if unconscious or altered sensorium
  • Age >18 years
  • On mechanical ventilation and expected to remain mechanically ventilated for at least 3 days
  • Documented pulmonary Pa colonization

Exclusion criteria

Exclusion Criteria:

  • Patients with known chronic pulmonary infection with Pa (i.e., patients with cystic fibrosis)
  • Patient currently diagnosed with Pa VAP
  • Change in systemic antibiotic therapy active against Gram negative bacteria within 72 hours
  • Use of an investigational medication within 4 weeks prior to randomization
05

Study design

Phase
Phase 1 / Phase 2
Primary purpose
Prevention
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Triple (Participant, Investigator, Outcomes assessor)
Enrollment
36 participants (estimated)

Study arms

  • Experimental
    1

    Low-dose KB001, a monoclonal antibody

    Biological: KB001

  • Experimental
    2

    High-dose KB001, a monoclonal antibody

    Biological: KB001

  • Placebo comparator
    3

    Placebo

    Biological: Placebo

Interventions

  • BiologicalKB001

    Single low-dose, administered intravenously

  • BiologicalKB001

    Single high-dose, administered intravenously

  • BiologicalPlacebo

    Placebo single-dose, administered intravenously

06

What researchers measure

Primary outcomes

  1. The safety and tolerability of a single dose of KB001.

    Time frame: Day 28

Secondary outcomes

  1. To measure the pharmacodynamic effects of a single-dose of KB001.

    Time frame: Day 28

07

Study locations

1 site
  • Multiple Cities, France
08

Timeline

Tracking since Sep 25, 2026
Not marked actual or estimatedDates not marked actual or estimated

The record gives a start of Apr 2008, a primary completion of Mar 2009 and a completion of Apr 2009. It does not say whether these dates are actual or estimated.

How these figures are worked out, and which studies are left out of them.

Registered
Jun 3, 2008
First posted
Jun 5, 2008
Start
Apr 2008
Primary completionActual
Mar 2009
CompletionActual
Apr 2009
Last update
Jul 31, 2009
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Jul 31, 2009, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT00691587
Lead sponsor
Humanigen, Inc.
First posted
Jun 5, 2008
Start date
Apr 2008
Primary completion
Mar 2009
Completion
Apr 2009
Last update
Jul 31, 2009

Study contacts

Prof. Jean Chastre
principal investigator · Hopital La Pitie Salpetriere

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Jul 2009. You cannot join it, but the record below documents what was studied.

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Discussion

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Humanigen, Inc.

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