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RECRUITING
NCT07402512
PHASE3

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

Sponsor: Simcere Pharmaceutical Co., Ltd

View on ClinicalTrials.gov

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

Interventions

DRUG

SIM0916

Dose: 20 mg/kg TID

DRUG

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