drugset / Trial / NCT07824167

The EMBRACE Study: Enflonsia Monoclonal in Babies - RSV Antibody Concentration Evaluation

NCT07824167 ↗

Phase 4 Not yet recruiting 24 enrolled Emory University Merck Sharp & Dohme LLC · collab
NaSingle-groupOpen-labelBasic science

Summary

Clesrovimab is an FDA-approved antibody drug recommended for infants younger than 8 months who are entering their first respiratory syncytial virus (RSV) season and whose mothers did not receive an RSV vaccine during pregnancy. It is given to help prevent severe RSV illness. This study will measure clesrovimab and other RSV antibodies in infants' blood and noses to learn how much of the drug reaches the nose, how long the antibodies remain, and how antibody levels change if an infant becomes infected with RSV.

Timeline

Start
2026-09
Primary completion
2028-03
Completion
2028-03

Drugs

EvaluationDrugModalityDoseRoute
Subject Clesrovimab Monoclonal antibody 105 mg Intramuscular