Clinical trial NCT01568762: To Compare the Safety, Tolerability, and Pharmacokinetics of QBX258 in Patients With Asthma
Official title: 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Asthma
Keywords: Asthma
VAK694
QAX576
QBX258
pharmacokinetics
Lead sponsor: Novartis
Sponsor class: INDUSTRY
First posted: 2012-04-02
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

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.


Eligibility 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.

Primary outcomes:
measure: Number of patients with adverse events
timeFrame: 100 days
Secondary outcomes:
measure: Concentration of serum anti-VAK694 antibodies
timeFrame: Pre-dose, Day 71, 85 and 100
measure: Concentration of serum anti-QAX576 antibodies
timeFrame: Pre-dose, Day 71, 85 and 100
measure: Area under the serum concentration curve for VAK694
timeFrame: Pre-dose, 1, 2, 4, 11, 24, 48, 96 hours and Days 8, 15, 29, 43, 57, 71, 85, 100
measure: Area under the serum concentration curve for QAX576
timeFrame: Pre-dose, 1, 2, 4, 11, 24, 48, 96 hours and Days 8, 15, 29, 43, 57, 71, 85, 100
measure: Change in interleukin concentrations
timeFrame: Pre-dose, 1, 2, 4, 11, 24, 48, 96 hours and Days 8, 15, 29, 43, 57, 71, 85, 100
Other outcomes:
Locations:
city: Raleigh
country: United States
facility: Novartis Investigative Site
state: North Carolina
Study officials:
affiliation: Novartis Pharmaceuticals
name: Novartis Pharmaceuticals
role: STUDY_DIRECTOR
References: