To Compare the Safety, Tolerability, and Pharmacokinetics of QBX258 in Patients With Asthma
Completed · Phase 1 · Has a placebo group
Conditions studied: Asthma
In brief
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.
Key facts
- Study ID
- NCT01568762
- Run by
- Novartis Pharmaceuticals
- People needed
- 50
- Starts
- 2010-10-01
- Last updated by the study team
- 2020-12-21
Who can join
Age: 18 and older, up to 60. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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
You may not qualify if…
- 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.
Where it is running
- Novartis Investigative Site — Raleigh, North Carolina, United States
Full record on ClinicalTrials.gov
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