ClinicalTrials.gov ID NCT06363370
Sponsor Kexing Biopharm Co., Ltd.
Information provided by Kexing Biopharm Co., Ltd. (Responsible Party)
Last Update Posted 2024-04-12
Brief 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.