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RECRUITING
NCT07095257
PHASE3

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

Sponsor: Nanjing Zenshine Pharmaceuticals

View on ClinicalTrials.gov

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.

Official title: 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

Key Details

Gender

All

Age Range

2 Years - 11 Years

Study Type

INTERVENTIONAL

Enrollment

168

Start Date

2025-10-13

Completion Date

2026-04-15

Last Updated

2025-11-19

Healthy Volunteers

No

Interventions

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.

Locations (2)

West China Second University Hospital, Sichuan University

Chengdu, Sichuan, China

Children's Hospital Zhejiang University School of Medicine

Hangzhou, Zhejiang, China