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
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
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Nirsevimab | Monoclonal antibody | 10 mg | Intramuscular |
| Subject | Nirsevimab | Monoclonal antibody | 25 mg | Intramuscular |
| Subject | Nirsevimab | Monoclonal antibody | 50 mg | Intramuscular |