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A Study of Deuremidevir Hydrobromide for Suspension in Chinese Infants Hospitalized With RSV

Respiratory Syncytial Virus Infection Clinical Trial

Official title:
A Randomized, Double-blind, Placebo-controlled Phase II/III Clinical Trial to Evaluate the Safety and Efficacy of Deuremidevir Hydrobromide for Suspension in Hospitalized Infants Infected With Respiratory Syncytial Virus.

Clinical Trial Summary

To evaluate the safety, efficacy, pharmacokinetic (PK) characteristics and antiviral activity of different doses of Deuterium Hydrobromide for suspension in the treatment of respiratory syncytial virus infection in infants.

Clinical Trial Description

This trial is a randomized, double-blind, placebo-controlled, dose-ascending trial, and the subjects are infants infected with RSV from 1 to 24 months. It is estimated that 60 subjects will be included and divided into low-dose group (15 mg/kg), middle-dose group (30 mg/kg) and high-dose group (50 mg/kg), with 20 cases in each group, and they will be randomly assigned to the experimental drug group and the placebo group according to the ratio of 3: 1. ;

Study Design

Related Conditions & MeSH terms

  • Respiratory Syncytial Virus Infection
  • Respiratory Syncytial Virus Infections
Clinical Trial Details
NCT number NCT06206720
Study type Interventional
Source Vigonvita Life Sciences
Contact Huaqing Duan
Phone 18061926005
Email huaqing.duan@vigonvita.cn
Status Recruiting
Phase Phase 2
Start date January 31, 2024
Completion date December 2024
View Details
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