drugset / Trial / NCT07402512
A Phase III Study of Deuremidevir Hydrobromide for the Treatment of RSV Infection in Infants and Young Children
RandomizedParallel-groupQuadruple-blindTreatment
Summary
This is a randomized, double-blind, placebo-controlled, parallel-group trial conducted in infants and young children aged 1 to 36 months with RSV infection. A total of 498 subjects are expected to be enrolled and randomly assigned to the investigational product group or the placebo group in a 2:1 ratio; Administration will be based on the subject's weight, with a dose of 20 mg/kg three times daily for 5 consecutive days (15 doses).
Timeline
- Start
- 2026-03-11
- Primary completion
- 2027-03-31
- Completion
- 2027-06-30
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | SIM0916 | Unknown | 20 mg/kg | Oral |