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Study Name: Safety Study of KB001 in People with CF and Pseudomonas aeruginosa
Study Type: Interventional
Intervention Category: Anti-Inflammatory
Study Sponsor: Kalobios
Study Phase: 1
Recruitment Status: Trial Completed
Study Drug(s): KB001-A
Number of Participants Being Recruited: 27
Single / Multi-Center: Multi-Center
STUDY BACKGROUND INFORMATION:
Pseudomonas aeruginosa (Pa) is the most common bacteria found in the lungs of people with CF. Up to 80% of CF patients eventually becoming infected with Pa. These patients are often treated with antibiotics with different results. This study looked at what a single-dose of an investigational drug, KB001, does to Pa bacteria in the CF lung.
ELIGIBILITY
Age: >= 12 Years
FEV1: >= 40 Percent Predicted
P. aeruginosa status: Positive
B. cepacia status: Negative
Other Primary Eligibility Requirements:

Note: Detailed eligibility criteria information may be available on clinicaltrials.gov. If a specific trial listing for this trial is available, a link to the specific clinicaltrials.gov listing will be present in the "More Information" section below.
FOR MORE INFORMATION:
Sponsor Contact Information:
Trial Specific Link on ClinicalTrials.gov: http://www.clinicaltrials.gov/ct2/show/NCT00638365?term=kalobios&rank=1
Clinical Research Terms Glossary: Click here
TRIAL RESULTS:
Primary Efficacy:

Twenty-seven CF patients were enrolled and randomized to receive one of two doses of KB001 or placebo. Preliminary results suggest a potential anti-inflammatory protective effect of KB001 based on changes noted in several sputum biomarkers.

Secondary Efficacy:

Not Applicable

Safety:

Both the high and low doses were well tolerated. No subject developed anti-KB001 antibodies.

The summary of data provided here is from an abstract presented at the Cystic Fibrosis Foundation North American CF Conference (2009). These data may be preliminary and have not been peer-reviewed.

Citation:

Not Available
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