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A Phase III Study of Deuremidevir Hydrobromide for the Treatment of RSV Infection in Infants and Young Children
Sponsor: Simcere Pharmaceutical Co., Ltd
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).
Official title: 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
Key Details
Gender
All
Age Range
1 Month - 36 Months
Study Type
INTERVENTIONAL
Enrollment
498
Start Date
2026-03-11
Completion Date
2027-06-30
Last Updated
2026-04-02
Healthy Volunteers
No
Conditions
Interventions
SIM0916
Dose: 20 mg/kg TID
SIM0916 Placebo
Dose: 20 mg/kg TID
Locations (4)
The First Affiliated Hospital Of Xiamen University
Xiamen, Fujian, China
Hunan Children's Hospital
Changsha, Hunan, China
West China Second University Hospital Sichuan University
Chengdu, Sichuan, China
Shulan(hangzhou)Hospital
Hangzhou, Zhejiang, China