Evaluating Onradivir Tablets Versus Placebo for Treating Influenza A in Adolescents Aged 12 to 17 Years

What this Trial Is About

Researchers are evaluating the safety and effectiveness of Onradivir Tablets in adolescents aged 12 to 17 years who have uncomplicated influenza A virus infection. This randomized, double-blind, placebo-controlled Phase III trial aims to compare Onradivir with a placebo to better understand treatment effects during the early stages of influenza A. Participants are randomly assigned in a 21 ratio to receive either Onradivir Tablets at 600 mg once daily or a matching placebo, both taken as 3 tablets per dose for 5 consecutive days. The study includes a screening period, a 5-day treatment period, and a safety follow-up period, with monitoring continuing until Day 14 after the first dose. During the trial, participants will provide nasopharyngeal swabs for viral testing at multiple points including screening and Days 2, 4, 5, and 10. They will also record body temperature, symptom severity, and daily activity using diary cards. Physical exams, vital signs, and lab tests occur at screening, Day 5, and Day 15. Researchers will monitor symptom relief, viral levels, fever resolution, complications, and medication use throughout the study.

A Multicenter, Randomized, Double-blind, Placebo-controlled Phase III Clinical Study to Evaluate the Safety and Efficacy of Onradivir Tablets in Participants Aged 12 to 17 Years With Uncomplicated Influenza A.