Safety, Pharmacodynamic and Pharmacokinetic Effects of QAX576 in Healthy Volunteers.
This study has been completed.
Information provided by:
First received: December 28, 2006
Last updated: September 30, 2010
Last verified: September 2010
This study is designed to evaluate the safety, pharmacodynamic and pharmacokinetic effects of individual escalating intravenous doses of QAX576 in healthy volunteers.
|Study Design:||Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Primary Purpose: Treatment
|Official Title:||A Randomized, Double-blind, Placebo-controlled Study to Assess the Safety, Pharmacokinetics and Pharmacodynamics of Single Escalating Doses of Intravenous QAX576|
Further study details as provided by Novartis:
Primary Outcome Measures:
- 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
Secondary Outcome Measures:
- 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.
|Study Start Date:||December 2006|
|Study Completion Date:||August 2007|
Contacts and Locations