NCT06206720

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

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.

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 60 (actual)
• Sponsor: Vigonvita Life Sciences · Industry
• Sex: All
• Age: 1 Month – 24 Months
• Healthy volunteers: Not accepted

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.

Detailed 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，BID), middle-dose group (20 mg/kg,BID) and high-dose group (20 mg/kg,TID), 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.

Conditions

• Respiratory Syncytial Virus Infection

Interventions

Type	Name	Description
DRUG	Deuremidevir Hydrobromide for Suspension	15 mg/kg BID group: 15 subjects will receive Deuremidevir Hydrobromide for Suspension once every 12 hours, total 10 times. 20 mg/kg BID group: 15 subjects will receive Deuremidevir Hydrobromide for Suspension once every 12 hours, total 10 times. 20 mg/kg TID group: 15 subjects will receive Deuremidevir Hydrobromide for Suspension 3 times every day, total 15 times.
DRUG	Placebo	15 mg/kg BID group: 5 subjects will receive placebo once every 12 hours, total 10 times. 20 mg/kg BID group: 5 subjects will receive placebo once every 12 hours, total 10 times. 20 mg/kg TID group: 5 subjects will receive placebo 3 times every day, total 15 times.

Timeline

• Start date: 2024-01-31
• Primary completion: 2025-06-16
• Completion: 2025-06-16
• First posted: 2024-01-16
• Last updated: 2025-07-23

Locations

22 sites across 1 country: China