Asthma
Conditions
Keywords
Asthma, VAK694, QAX576, QBX258, pharmacokinetics
Brief summary
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.
Interventions
DRUGVAK694
Intravenous infusion
DRUGVAK694 placebo
Intravenous infusion
DRUGQAX576
Intravenous infusion
DRUGQAX576 placebo
Intravenous infusion
Sponsors
Novartis Pharmaceuticals
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to 60 Years
Healthy volunteers
No
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/
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of patients with adverse events | 100 days | Adverse events will be determined by evaluating clinical, laboratory evaluations, impact on vital signs and impacts on ECGs |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Concentration of serum anti-VAK694 antibodies | Pre-dose, Day 71, 85 and 100 | Blood will be collected to determine concentrations if anti-VAK964 antibodies |
| Concentration of serum anti-QAX576 antibodies | Pre-dose, Day 71, 85 and 100 | Blood will be collected to determine concentrations if anti-QAX576 antibodies |
| Area under the serum concentration curve for VAK694 | Pre-dose, 1, 2, 4, 11, 24, 48, 96 hours and Days 8, 15, 29, 43, 57, 71, 85, 100 | Blood will be collected for the measurement of VAK694 serum concentrations |
| Area under the serum concentration curve for QAX576 | Pre-dose, 1, 2, 4, 11, 24, 48, 96 hours and Days 8, 15, 29, 43, 57, 71, 85, 100 | Blood will be collected for the measurement of QAX576 concentrations |
| Change in interleukin concentrations | Pre-dose, 1, 2, 4, 11, 24, 48, 96 hours and Days 8, 15, 29, 43, 57, 71, 85, 100 | Blood samples will be collected to measure interleukin concetrations. |
Countries
United States
Outcome results
None listed