NCT07402512

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

A Phase III, Randomized, Double-Blind, Placebo-Controlled Clinical Trial to Evaluate the Efficacy and Safety of Deurremidevir Hydrobromide for Oral Suspension in Infants and Young Children With Respiratory Syncytial Virus Infection

• Status: Recruiting
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 498 (estimated)
• Sponsor: Simcere Pharmaceutical Co., Ltd · Academic / Other
• Sex: All
• Age: 1 Month – 36 Months
• Healthy volunteers: Not accepted

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).

Conditions

• Respiratory Syncytial Virus Infection

Interventions

Type	Name	Description
DRUG	SIM0916	Dose: 20 mg/kg TID
DRUG	SIM0916 Placebo	Dose: 20 mg/kg TID

Timeline

• Start date: 2026-03-11
• Primary completion: 2027-03-31
• Completion: 2027-06-30
• First posted: 2026-02-11
• Last updated: 2026-04-02

Locations

4 sites across 1 country: China