drugset / Trial / NCT02290340

A Phase 1b/2a Randomized, Double-Blind, Placebo-controlled, Dose-escalation Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of MEDI8897, a Monoclonal Antibody With an Extended Half-life Against Respiratory Syncytial Virus, in Healthy Preterm Infants

NCT02290340

Phase 1 Completed 151 enrolled MedImmune LLC
RandomizedParallel-groupQuadruple-blindPrevention

Summary

The purpose of this study is to evaluate the safety, tolerability and pharmacokinetics of an extended half-life anti-respiratory syncytial virus (RSV) monoclonal antibody compared to placebo when administered to healthy preterm infants.

Timeline

Start
2015-01-13
Primary completion
2016-09-28
Completion
2016-09-28

Drugs

EvaluationDrugModalityDoseRoute
Subject Nirsevimab Monoclonal antibody 10 mg Intramuscular
Subject Nirsevimab Monoclonal antibody 25 mg Intramuscular
Subject Nirsevimab Monoclonal antibody 50 mg Intramuscular