drugset / Trial / NCT07824167
The EMBRACE Study: Enflonsia Monoclonal in Babies - RSV Antibody Concentration Evaluation
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
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Clesrovimab | Monoclonal antibody | 105 mg | Intramuscular |