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

Study Overview
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Brief Summary
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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)

Detailed Description
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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.

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

Conditions
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Cystic Fibrosis

Intervention / Treatment
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* Biological: KB001
* Other: Placebo


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 12 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 1<br>KB001, a monoclonal antibody | Biological: KB001<br>* Single-dose, 3mg/kg or 10mg/kg dose administered intravenously<br>* Other names: KB001-recombinant human anti-Pa PcrV Fab antibody;|
| Placebo Comparator: 2<br>Placebo | Other: Placebo<br>* Placebo single-dose administered intravenously<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The Safety and Tolerability of a Single-dose of KB001. | Safety assessments were conducted after completion of day 28. AEs were followed through completion of day 56. | Day 28 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Cystic Fibrosis, Pseudomonas aeruginosa, Pulmonary CF