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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| VAK694 | Experimental | VAK694 was administered as a 1 hour intravenous infusion |
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| VAK694 Placebo | Placebo Comparator | VAK694 placebo was administered as a one hour intravenous infusion |
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| QAX576 | Experimental | QAX576 was administered intravenously as a 2 hour infusion |
|
| QAX576 placebo | Placebo Comparator | QAX576 placebo was administered as a 2 hour intravenous infusion |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| VAK694 | Drug | Intravenous infusion |
| |
| VAK694 placebo |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Concentration of serum anti-VAK694 antibodies | Blood will be collected to determine concentrations if anti-VAK964 antibodies | Pre-dose, Day 71, 85 and 100 |
| Concentration of serum anti-QAX576 antibodies |
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Inclusion Criteria:
Exclusion Criteria:
Other protocol-defined inclusion/exclusion criteria may apply.
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| Name | Affiliation | Role |
|---|---|---|
| Novartis Pharmaceuticals | Novartis Pharmaceuticals | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Novartis Investigative Site | Raleigh | North Carolina | 27607 | United States |
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| Label | URL |
|---|---|
| Results forCQBX258X2101 can be found on the Novartis Clinical Trial Results Website | View source |
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| ID | Term |
|---|---|
| D001249 | Asthma |
| ID | Term |
|---|---|
| D001982 | Bronchial Diseases |
| D012140 | Respiratory Tract Diseases |
| D008173 | Lung Diseases, Obstructive |
| D008171 | Lung Diseases |
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| Drug |
Intravenous infusion |
|
| QAX576 | Drug | Intravenous infusion |
|
| QAX576 placebo | Drug | Intravenous infusion |
|
Blood will be collected to determine concentrations if anti-QAX576 antibodies
| Pre-dose, Day 71, 85 and 100 |
| 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 |
| 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 |
| 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 |
| D012130 |
| Respiratory Hypersensitivity |
| D006969 | Hypersensitivity, Immediate |
| D006967 | Hypersensitivity |
| D007154 | Immune System Diseases |