To Compare the Safety, Tolerability, and Pharmacokinetics of QBX258 in Patients With Asthma

Study Overview
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Brief Summary
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This study is designed to compare the safety, tolerability, and pharmacokinetics of QBX258 (sequential administration of a fixed dose of VAK694 and single ascending doses of QAX576) in patients with well-controlled mild to moderate asthma.

Official Title
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A Randomized, Double-blind, Placebo Controlled Study to Compare the Safety, Tolerability, and Pharmacokinetics of QBX258 (Sequential Administration of a Fixed Dose of VAK694 and Single Ascending Doses of QAX576) in Patients With Well-controlled Mild to Moderate Asthma

Conditions
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Asthma

Intervention / Treatment
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* Drug: VAK694
* Drug: VAK694 placebo
* Drug: QAX576
* Drug: QAX576 placebo


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Male and female subjects age 18-60 years (inclusive) Well controlled mild to moderate atopic asthma Female subjects must be post-menopausal or surgically sterile Male subjects must be using two methods of contraception Subjects must have a positive skin prick test to one or more common airborne allergen Exclusion Criteria: Participation in any clinical investigation or use of other investigational drugs at time of enrollment A history of clinically significant ECG abnormalities History of malignancy of any organ system Smokers (use of tobacco products in the previous 3 months) Use of prescription drugs other than those required for control and relief of asthma Use of oral steroids within 12 weeks prior to dosing FEVI < 80% predicted at screening or baseline Use of albuterol more than twice a week for relief of asthma Patients suffering from active hay fever at baseline or likely to require treatment during the study History of chronic respiratory disease other than asthma or chronic allergic rhinitis Emergency room visit within 6 weeks of screening due to asthma Hospitalization for asthma in the last year History of intubation/assisted ventilation for asthma in the last 5 years Administration of live vaccines within the preceding month Other protocol-defined inclusion/exclusion criteria may apply.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 60 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: Other
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: VAK694<br>VAK694 was administered as a 1 hour intravenous infusion | Drug: VAK694<br>* Intravenous infusion<br>|
| Placebo Comparator: VAK694 Placebo<br>VAK694 placebo was administered as a one hour intravenous infusion | Drug: VAK694 placebo<br>* Intravenous infusion<br>|
| Experimental: QAX576<br>QAX576 was administered intravenously as a 2 hour infusion | Drug: QAX576<br>* Intravenous infusion<br>|
| Placebo Comparator: QAX576 placebo<br>QAX576 placebo was administered as a 2 hour intravenous infusion | Drug: QAX576 placebo<br>* Intravenous infusion<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of patients with adverse events | Adverse events will be determined by evaluating clinical, laboratory evaluations, impact on vital signs and impacts on ECGs | 100 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Concentration of serum anti-VAK694 antibodies | Blood will be collected to determine concentrations if anti-VAK964 antibodies | Pre-dose, Day 71, 85 and 100 | 
| Concentration of serum anti-QAX576 antibodies | Blood will be collected to determine concentrations if anti-QAX576 antibodies | Pre-dose, Day 71, 85 and 100 | 
| Area under the serum concentration curve for VAK694 | Blood will be collected for the measurement of VAK694 serum concentrations | Pre-dose, 1, 2, 4, 11, 24, 48, 96 hours and Days 8, 15, 29, 43, 57, 71, 85, 100 | 
| Area under the serum concentration curve for QAX576 | Blood will be collected for the measurement of QAX576 concentrations | Pre-dose, 1, 2, 4, 11, 24, 48, 96 hours and Days 8, 15, 29, 43, 57, 71, 85, 100 | 
| Change in interleukin concentrations | Blood samples will be collected to measure interleukin concetrations. | Pre-dose, 1, 2, 4, 11, 24, 48, 96 hours and Days 8, 15, 29, 43, 57, 71, 85, 100 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Asthma, VAK694, QAX576, QBX258, pharmacokinetics