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
Completed · Phase 1 · Has a placebo group
Conditions studied: Respiratory Syncytial Virus
In brief
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.
Key facts
- Study ID
- NCT02290340
- Run by
- MedImmune LLC
- People needed
- 151
- Starts
- 2015-01-13
- Expected to finish
- 2016-09-28
- Last updated by the study team
- 2018-09-19
Who can join
Age: any, up to 1. Sex: any. Healthy volunteers: accepted.
Where it is running
- Research Site — Anaheim, California, United States
- Research Site — Ontario, California, United States
- Research Site — Syracuse, New York, United States
- Research Site — Cleveland, Ohio, United States
- Research Site — Charleston, South Carolina, United States
- Research Site — St. George, Utah, United States
- Research Site — Marshfield, Wisconsin, United States
- Research Site — Santiago, Chile
- Research Site — Valdivia, Chile
- Research Site — Cape Town, South Africa
- Research Site — East London, South Africa
- Research Site — Johannesburg, South Africa
- Research Site — Pretoria, South Africa
Full record on ClinicalTrials.gov
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