NCT06363370

Human Interferon α1b Inhalation Solution Against Respiratory Syncytial Virus in Children With Lower Respiratory Tract Infections

A Multicenter, Randomized, Double-blind, Placebo-controlled Phase III Clinical Study to Evaluate the Safety and Efficacy of Human Interferon α1b Inhaled Solution in the Treatment of Respiratory Syncytial Virus Lower Respiratory Tract Infection in Children.

• Status: Recruiting
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 322 (estimated)
• Sponsor: Kexing Biopharm Co., Ltd. · Industry
• Sex: All
• Age: 2 Months – 2 Years
• Healthy volunteers: Not accepted

Summary

To evaluate the efficacy and safety of interferon α1b (GB05) in the treatment of children under 2 years of age with respiratory syncytial virus infection.

Detailed description

The study has been divided into two parts, 60 subjects will be randomly assigned to the 4μg/kg dose group or 6μg/kg dose group or the blank control group, to receive nebulized GB05 therapy, twice daily for no more than 7 days. After comprehensive evaluation of effectiveness and safety, and confirmation of the optimal dose, the sample size will be re-calculated to enter the second part of the study.

Conditions

• Respiratory Syncytial Virus Infections

Interventions

Type	Name	Description
DRUG	Human interferon α1b Inhalation Solution	Participants will receive Human interferon α1b Inhalation Solution
DRUG	Inhalation Solution Placebo	Participants will receive Inhalation Solution Placebo

Timeline

• Start date: 2024-03-27
• Primary completion: 2026-06-30
• Completion: 2026-06-30
• First posted: 2024-04-12
• Last updated: 2024-04-12

Locations

1 site across 1 country: China