Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of QAX576 in Asthma Patients
NCT ID: NCT00940160
Last Updated: 2020-12-21
Study Results
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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COMPLETED
PHASE1/PHASE2
30 participants
INTERVENTIONAL
2009-07-31
Brief Summary
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Detailed Description
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Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
TRIPLE
Study Groups
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QAX576 1 mg/kg
QAX576
QAX576 3 mg/kg
QAX576
QAX576 10 mg/kg
QAX576
Placebo
Placebo
Interventions
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QAX576
QAX576
QAX576
Placebo
Eligibility Criteria
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Inclusion Criteria
* Controlled or partially controlled asthma as defined in GINA 2007.
* At Screening, and Baseline, vital signs (systolic and diastolic blood pressure and pulse rate) will be assessed after the subject has rested for at least three (3) minutes.
* Female subjects must be post-menopausal as confirmed by FSH ≥ 40, or have been surgically sterilized at least 6 months prior to screening.
* Subjects must have a body mass index (BMI) within the range of 18 to 30 kg/m2.
* Male subjects must be using two methods of contraception, i.e., spermicidal gel plus condom, for the entire duration of the study, up to Study Completion visit, and refrain from fathering a child in the six (6) months after study completion
Exclusion Criteria
* Use of any prescription drugs other than stable (4 weeks) use of hormone replacement or thyroid replacement within four (4) weeks prior to dosing (other than medication required for treatment of asthma).
* Use of any over the counter (OTC) medication within forty eight (48) hours prior to dosing.
* Use of oral steroids within 12 weeks prior to dosing.
* Patients who have received an investigational drug in any clinical investigation within 4 weeks prior to dosing or longer if required by local regulations, and for any other limitation of participation based on local regulations.
* Any immunotherapy with systemic biologics as a treatment therapy or during a clinical study with in the last 6 months.
* Any immunotherapy with subcutaneous injections for allergy (allergy shots), within 3 months.
* Donation or loss of 400 mL or more of blood within 8 weeks prior to first dosing, or longer if required by local regulation.
* Patients suffering from hay fever at screening or likely to require treatment during the study.
* History of chronic respiratory disease other than asthma or chronic allergic rhinitis.
* Hospitalization for asthma in the last year.
* History of intubation/assisted ventilation for asthma in the last 5 years.
* History of autonomic dysfunction (e.g. history of fainting, orthostatic hypotension).
* History or presence of any surgical or medical condition or clinically significant abnormal laboratory findings, which, in the opinion of the investigator, may jeopardize the subject in case of participation in the study.
* History of drug or alcohol abuse within the 12 months prior to dosing or evidence of such abuse as indicated by the laboratory assays conducted during the screening or baseline evaluations.
* History of clinical schistosomiasis or travel within the preceding 6 months to an area with endemic schistosomiasis, including but not limited to Southeast Asia and Northwest Africa.
18 Years
65 Years
ALL
No
Sponsors
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Novartis Pharmaceuticals
INDUSTRY
Responsible Party
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Novartis Pharmaceuticals
Principal Investigators
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Novartis Pharmaceuticals
Role: STUDY_DIRECTOR
Novartis Pharmaceuticals
Locations
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Novartis Investigator Site
Moscow, , Russia
Novartis Investigator Site
Saint Petersburg, , Russia
Novartis Investigator Site
Manchester, , United Kingdom
Countries
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Related Links
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Results for CQAX576A2107 can be found on the Novartis Clinical Trial Results Website
Other Identifiers
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CQAX576A2107
Identifier Type: -
Identifier Source: org_study_id