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

A Multicenter, Randomized, Double-blind, Positive Controlled, Phase III Trial to Evaluate the Safety and Efficacy of ZX-7101A for Oral Suspension in Pediatric Participants Aged 2 to 11 With Influenza

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 169 (actual)
• Sponsor: Nanjing Zenshine Pharmaceuticals · Industry
• Sex: All
• Age: 2 Years – 11 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Respiratory Viral Infection

Interventions

Type	Name	Description
DRUG	ZX-7101A for oral suspension	ZX-7101A will be administered as oral suspension in a single dose on Day 1. Oseltamivir phosphate matching placebo will also be administered as oral suspension twice daily (BID) for 5 days.
DRUG	Oseltamivir phosphate for oral suspension	Oseltamivir phosphate will be administered as oral suspension BID for 5 days. Participants receiving oseltamivir will also receive ZX-7101A matching placebo as oral suspension, single dose on Day 1.

Timeline

• Start date: 2025-10-13
• Primary completion: 2026-01-16
• Completion: 2026-01-16
• First posted: 2025-07-31
• Last updated: 2026-04-16

Locations

2 sites across 1 country: China