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

Asthma Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01568762
• Other study ID #: CQBX258X2101
• Status: Completed
• Phase: Phase 1
• Start date: October 2010

Study information

• Verified date: March 2012
• Source: Novartis
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 50
• Est. primary completion date: July 2011
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 60 Years

Eligibility

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.

Related Conditions & MeSH terms

• Asthma

Intervention

Drug:
• VAK694
Intravenous infusion
• VAK694 placebo
Intravenous infusion
• QAX576
Intravenous infusion
• QAX576 placebo
Intravenous infusion

Locations

Country	Name	City	State
United States	Novartis Investigative Site	Raleigh	North Carolina

Sponsors (1)

Lead Sponsor	Collaborator
Novartis Pharmaceuticals

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of patients with adverse events	Adverse events will be determined by evaluating clinical, laboratory evaluations, impact on vital signs and impacts on ECGs	100 days
Secondary	Concentration of serum anti-VAK694 antibodies	Blood will be collected to determine concentrations if anti-VAK964 antibodies	Pre-dose, Day 71, 85 and 100
Secondary	Concentration of serum anti-QAX576 antibodies	Blood will be collected to determine concentrations if anti-QAX576 antibodies	Pre-dose, Day 71, 85 and 100
Secondary	Area under the serum concentration curve for VAK694	Blood will be collected for the measurement of VAK694 serum concentrations	Pre-dose, 1, 2, 4, 11, 24, 48, 96 hours and Days 8, 15, 29, 43, 57, 71, 85, 100
Secondary	Area under the serum concentration curve for QAX576	Blood will be collected for the measurement of QAX576 concentrations	Pre-dose, 1, 2, 4, 11, 24, 48, 96 hours and Days 8, 15, 29, 43, 57, 71, 85, 100
Secondary	Change in interleukin concentrations	Blood samples will be collected to measure interleukin concetrations.	Pre-dose, 1, 2, 4, 11, 24, 48, 96 hours and Days 8, 15, 29, 43, 57, 71, 85, 100

External Links

•   Results forCQBX258X2101 can be found on the Novartis Clinical Trial Results Website