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OpenTrials
Completed

NCT Number: NCT01568762

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

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.

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Key information

Age range

18 year–60 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Novartis Investigative Site

Raleigh, North Carolina, 27607, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

VAK694

Drug

Intravenous infusion

VAK694 placebo

Drug

Intravenous infusion

QAX576

Drug

Intravenous infusion

QAX576 placebo

Drug

Intravenous infusion

Primary outcomes

  1. Number of patients with adverse events

    Time frame: 100 days

    Adverse events will be determined by evaluating clinical, laboratory evaluations, impact on vital signs and impacts on ECGs

Secondary outcomes

  1. Concentration of serum anti-VAK694 antibodies

    Time frame: Pre-dose, Day 71, 85 and 100

    Blood will be collected to determine concentrations if anti-VAK964 antibodies

  2. Concentration of serum anti-QAX576 antibodies

    Time frame: Pre-dose, Day 71, 85 and 100

    Blood will be collected to determine concentrations if anti-QAX576 antibodies

  3. Area under the serum concentration curve for VAK694

    Time frame: 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

  4. Area under the serum concentration curve for QAX576

    Time frame: 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

  5. Change in interleukin concentrations

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

Novartis Pharmaceuticals

Industry

Registry information

Official study 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

Important dates

Study start
2010
Primary completion
2011
First posted
Apr 2, 2012
Registry last updated
Dec 21, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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