drugset / Trial / NCT07402512

A Phase III Study of Deuremidevir Hydrobromide for the Treatment of RSV Infection in Infants and Young Children

NCT07402512 ↗

Phase 3 Recruiting 498 enrolled Simcere Pharmaceutical Co., Ltd
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

EvaluationDrugModalityDoseRoute
Subject SIM0916 Unknown 20 mg/kg Oral