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This study is designed to evaluate the safety, pharmacodynamic and pharmacokinetic effects of individual escalating intravenous doses of QAX576 in healthy volunteers.
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| QAX576 | Drug |
| Measure | Description | Time Frame |
|---|---|---|
| Safety and tolerability of single escalating doses of QAX576 as assessed by vital signs, electrocardiogram (ECG), adverse events, laboratory evaluations, up to 96 hours after drug administration, and telemetry up until 24 hours post dose |
| Measure | Description | Time Frame |
|---|---|---|
| Exploration of pharmacokinetics of QAX576 and its pharmacodynamic effects on interleukin 13 (IL-13) concentration data. Samples collection at pre-dose and up to 48 hours post-dose. | ||
| Assess the immunogenicity of QAX576 in healthy subjects. |
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Inclusion Criteria:
Oral body temperature 35.0-37.5°C. Supine systolic blood pressure, 90-140 mm Hg. Supine diastolic blood pressure, 50-90 mm Hg. Supine pulse rate, 50-90 beats per minute (bpm).
Exclusion Criteria:
Other protocol-defined inclusion/exclusion criteria may apply
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| Name | Affiliation | Role |
|---|---|---|
| Novartis | Investigator site | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Novartis Investigative Site | East Hanover | New Jersey | 07936-1080 | United States |
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