drugset / Trial / NCT07095257

Study to Assess the Safety and Efficacy of ZX-7101A for Oral Suspension in Chinese Pediatric Participants 2 to 11 Years of Age With Influenza

NCT07095257

Phase 3 Completed 169 enrolled Nanjing Zenshine Pharmaceuticals
RandomizedParallel-groupQuadruple-blindTreatment

Summary

The goal of this phase III study is to learn if ZX-7101A for oral suspension works to treat uncomplicated influenza in Pediatric Participants aged 2 to 11 years. The main question it aims to answer is: What medical problems do participants have when taking drug ZX-7101A for oral suspension or Oseltamivir phosphate for oral suspension? Researchers will compare drug ZX-7101A for oral suspension to active comparator: Oseltamivir phosphate for oral suspension to see if drug ZX-7101A for oral suspension works to treat uncomplicated influenza in Pediatric Participants aged 2 to 11 years.

Timeline

Start
2025-10-13
Primary completion
2026-01-16
Completion
2026-01-16

Drugs

EvaluationDrugModalityDoseRoute
Comparator Oseltamivir Small molecule 0.36 g Oral
Subject ZX-7101A Unknown 10 mg Oral