To Compare the Safety, Tolerability, and Pharmacokinetics of QBX258 in Patients With Asthma
- Conditions
- Asthma
- Interventions
- Registration Number
- NCT01568762
- Lead Sponsor
- Novartis Pharmaceuticals
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 50
- 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
- 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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description VAK694 Placebo VAK694 placebo VAK694 placebo was administered as a one hour intravenous infusion QAX576 QAX576 QAX576 was administered intravenously as a 2 hour infusion QAX576 placebo QAX576 placebo QAX576 placebo was administered as a 2 hour intravenous infusion VAK694 VAK694 VAK694 was administered as a 1 hour intravenous infusion
- Primary Outcome Measures
Name Time Method 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 Outcome Measures
Name Time Method 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.
Trial Locations
- Locations (1)
Novartis Investigative Site
🇺🇸Raleigh, North Carolina, United States