Safety, Tolerability and Pharmacokinetic Study of Single and Multiple Intravenous Doses of RSV604 in Healthy Subjects.
This study has been completed.
Information provided by (Responsible Party):
Novartis ( Novartis Pharmaceuticals )
First received: December 27, 2006
Last updated: November 1, 2011
Last verified: November 2011
This study is designed to evaluate the safety, tolerability and pharmacokinetics of single and multiple-dose escalation of RSV604 administered intravenously in healthy subjects.
|Study Design:||Allocation: Randomized
Endpoint Classification: Safety Study
Intervention Model: Parallel Assignment
Primary Purpose: Treatment
|Official Title:||A Randomized, Double-blind Placebo-controlled Single- to Multiple-dose Escalation Study to Investigate the Safety, Tolerability and Pharmacokinetics of RSV604 Intravenous Formulation in Healthy Subjects|
Further study details as provided by Novartis:
Primary Outcome Measures:
- Safety and tolerability of single and multiple intravenous doses of RSV604 as measured by vital signs, electrocardiographs (ECGs), adverse events, clinical laboratory evaluations.
- Tolerability of single and multiple intravenous doses of RSV604, RSV604 as measured by vital signs, ECGs, adverse events, clinical laboratory evaluations
Secondary Outcome Measures:
- Pharmacokinetics of single-dose RSV604 intravenous formulation administered orally and intravenously
|Study Start Date:||October 2006|
|Primary Completion Date:||November 2006 (Final data collection date for primary outcome measure)|
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