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

NCT ID: NCT01568762

Last Updated: 2020-12-21

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

50 participants

Study Classification

INTERVENTIONAL

Study Start Date

2010-10-31

Brief Summary

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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.

Detailed Description

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Conditions

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Asthma

Keywords

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Asthma VAK694 QAX576 QBX258 pharmacokinetics

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

OTHER

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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VAK694

VAK694 was administered as a 1 hour intravenous infusion

Group Type EXPERIMENTAL

VAK694

Intervention Type DRUG

Intravenous infusion

VAK694 Placebo

VAK694 placebo was administered as a one hour intravenous infusion

Group Type PLACEBO_COMPARATOR

VAK694 placebo

Intervention Type DRUG

Intravenous infusion

QAX576

QAX576 was administered intravenously as a 2 hour infusion

Group Type EXPERIMENTAL

QAX576

Intervention Type DRUG

Intravenous infusion

QAX576 placebo

QAX576 placebo was administered as a 2 hour intravenous infusion

Group Type PLACEBO_COMPARATOR

QAX576 placebo

Intervention Type DRUG

Intravenous infusion

Interventions

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VAK694

Intravenous infusion

Intervention Type DRUG

VAK694 placebo

Intravenous infusion

Intervention Type DRUG

QAX576

Intravenous infusion

Intervention Type DRUG

QAX576 placebo

Intravenous infusion

Intervention Type DRUG

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

60 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Novartis Pharmaceuticals

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Novartis Pharmaceuticals

Role: STUDY_DIRECTOR

Novartis Pharmaceuticals

Locations

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Novartis Investigative Site

Raleigh, North Carolina, United States

Site Status

Countries

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United States

Related Links

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https://www.novctrd.com/ctrdweb/trialresult/trialresults/pdf?trialResultId=6763

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

Other Identifiers

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CQBX258X2101

Identifier Type: -

Identifier Source: org_study_id