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

• Status: Completed
• Trial end date: 1969-12-31
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Novartis Pharmaceuticals

Criteria

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.