Safety, Pharmacodynamic and Pharmacokinetic Effects of QAX576 in Healthy Volunteers.
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|ClinicalTrials.gov Identifier: NCT00417196|
Recruitment Status : Completed
First Posted : December 29, 2006
Last Update Posted : October 1, 2010
|Condition or disease||Intervention/treatment||Phase|
|Healthy||Drug: QAX576||Phase 1|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||32 participants|
|Intervention Model:||Parallel Assignment|
|Official Title:||A Randomized, Double-blind, Placebo-controlled Study to Assess the Safety, Pharmacokinetics and Pharmacodynamics of Single Escalating Doses of Intravenous QAX576|
|Study Start Date :||December 2006|
|Study Completion Date :||August 2007|
- 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
- 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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00417196
|United States, New Jersey|
|Novartis Investigative Site|
|East Hanover, New Jersey, United States, 07936-1080|
|Principal Investigator:||Novartis||Investigator site|