At a glance
ClinicalIndex Comparison Record- ✓Previously healthy children
- ✓Age 24 months or younger at randomization
- ✓Gestational age ≥36 weeks
- ✓Hospitalized for lower respiratory tract RSV illness (bronchiolitis and/or pneumonia)
- ✕Prior or concurrent ribavirin or other antiviral treatment for current RSV episode
- ✕Required intubation for ventilatory support
- ✕Any medically significant underlying chronic illness or acute illness other than RSV infection
- ✕Known renal impairment, hepatic dysfunction, hematologic abnormalities, seizure, neurologic disorder, or immunodeficiency
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
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
In Brief
A Phase 1 clinical trial evaluating Motavizumab and Placebo for Respiratory Syncytial Virus Prophylaxis. Completed, enrolled 31 participants.
Detailed 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).
Study Details
Timeline
Interventions
Single dose of Motavizumab at a dose of 3 mg/kg administered intravenously (in the vein) on Day 0
Single dose of Motavizumab at a dose of 15 mg/kg administered intravenously (in the vein) on Day 0
Single dose of Motavizumab at a dose of 30 mg/kg administered intravenously (in the vein) on Day 0
Single dose of placebo administered intravenously (in the vein) on Day 0