Clinical Trial: A Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Immunogenicity of a Single Intravenous Dose of MEDI-524, a Humanized Enhanced Potency Monoclonal Antibody to Respiratory Syncytial Virus (RSV), in Otherwise Healthy Children Hospitalized With RSV Infection
Study Status: Completed
Recruit Status: Completed
Study Type: Interventional
Official Title: A Phase 1, Randomized, Placebo-Controlled, Dose-Escalation Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Immunogenicity of a Single Intravenous Dose of MEDI-524, a Humanized Enhanc
Brief Summary: MEDI-524 administered as a single IV dose at 3, 15, and 30 mg/kg to children hospitalized with RSV infection was safe and well tolerated.
Detailed Summary:
Sponsor: MedImmune LLC
Current Primary Outcome:
- To describe the safety and tolerability of a single intravenous dose of MEDI-524
- To describe the serum concentrations of IV administered MEDI-524
Original Primary Outcome:
- - To describe the safety and tolerability of a single intravenous dose of MEDI-524 administered at 3 mg/kg, 15 mg/kg, and 30 mg/kg in otherwise healthy infants hospitalized for RSV infection
- - To describe the serum concentrations of IV administered MEDI-524 in these children with RSV infection
Current Secondary Outcome: To describe the immunogenicity of MEDI-524 following a single IV dose
Original Secondary Outcome: - To describe the immunogenicity of MEDI-524 following a single IV dose
Information By: MedImmune LLC
Dates:
Date Received: September 13, 2005
Date Started: March 2004
Date Completion: January 2005
Last Updated: October 23, 2006
Last Verified: October 2006
