NCT00192504

Safety Study of a Monoclonal Antibody to Respiratory Syncytial Virus (RSV) in Children Hospitalized With RSV Infection

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 Enhanced Potency Monoclonal Antibody to Respiratory Syncytial Virus (RSV), in Otherwise Healthy Children Hospitalized With RSV Infection

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 31 (actual)
• Sponsor: MedImmune LLC · Industry
• Sex: All
• Age: 24 Months
• Healthy volunteers: Not accepted

Summary

The purpose of this study is to determine the safety of motavizumab (MEDI-524) following a single intravenous dose in children hospitalized with respiratory syncytial virus (RSV).

Detailed description

This study was designed as a Phase 1, randomized, double-blind, placebo-controlled, dose-escalation, multicenter clinical study to evaluate the safety, tolerability, serum concentrations, and immunogenicity of a single intravenous dose of motavizumab (MEDI-524) and the effect on the amount of respirtory syncytial virus (RSV) in the respiratory tract (nasopharynx) of otherwise healthy children hospitalized with RSV infection.

Conditions

• Respiratory Syncytial Virus Prophylaxis

Interventions

Type	Name	Description
BIOLOGICAL	Motavizumab	Single dose of Motavizumab at a dose of 3 mg/kg administered intravenously (in the vein) on Day 0
BIOLOGICAL	Motavizumab	Single dose of Motavizumab at a dose of 15 mg/kg administered intravenously (in the vein) on Day 0
BIOLOGICAL	Motavizumab	Single dose of Motavizumab at a dose of 30 mg/kg administered intravenously (in the vein) on Day 0
OTHER	Placebo	Single dose of placebo administered intravenously (in the vein) on Day 0

Timeline

• Start date: 2004-03-01
• Primary completion: 2005-01-01
• Completion: 2005-01-01
• First posted: 2005-09-19
• Last updated: 2021-10-08
• Results posted: 2021-10-08