NCT06669351

Study to Assess the Safety and Efficacy of ZX-7101A in Children Aged 5-11 Years With Influenza

A Multicenter, Randomized, Double-blind, Positive Controlled Phase Ⅲ Clinical Trial of ZX-7101A Tablets to Evaluate the Safety and Efficacy in the Treatment of Uncomplicated Influenza in Children Aged 5-11 Years

• Status: Terminated
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 98 (actual)
• Sponsor: Nanjing Zenshine Pharmaceuticals · Industry
• Sex: All
• Age: 5 Years – 11 Years
• Healthy volunteers: Not accepted

Summary

A multicenter, randomized, double-blind, positive controlled, phase III trial to evaluate the safety and efficacy of ZX-7101A tablets versus oseltamivir phosphate suspension in children aged ≥5 years and \< 12 years with uncomplicated influenza.

Detailed description

Part 1: A pilot study of pharmacokinetics, safety, and efficacy was conducted in children (5-11 years old, weight ≥20kg) with uncomplicated influenza. A total of 12 subjects were planned to be enrolled. (Pharmacokinetic and safety data from at least 8 children are required.) On the first day, ZX-7101A 20 mg tablets, 2 tablets (specification: 10 mg/ tablet) were taken orally. PK samples were collected before and after the first (D1) dose: 1 to 2 h, 4 h, 8 h, 24 h (D2), 96 h (D5), 192 h (D9) and 336 h (D15) after administration. Part 2: A randomized phase III study with safety as primary endpoint was conducted in children (5-11 years old, body weight ≥20kg) with uncomplicated influenza. Eligible subjects were randomly assigned in a 2:1 ratio to receive either ZX-7101A or oseltamivir phosphate. Enrolled subjects were required to have typical systemic and/or respiratory influenza symptoms, with first influenza symptoms occurring within 48 hours of randomization. The study was divided into a screening/treatment period (D1) and an observation period (approximately 2 weeks).

Conditions

• Respiratory Viral Infection

Interventions

Type	Name	Description
DRUG	ZX-7101A	On day1: Take two tablets of ZX-7101A orally once (specification: 10mg/ tablet) with appropriate amount of warm water
OTHER	Placebo for ZX-7101A tablet	Placebo for ZX-7101A tablet: The appearance and properties of placebo tablets were identical to those of the trial drug ZX-7101A tablets. On Day 1, two placebo for ZX-7101A tablets were taken orally with appropriate warm water.
DRUG	Oseltamivir phosphate dry suspension	Drug: Oseltamivir phosphate dry suspension: From Day1 to Day 5 : Oseltamivir phosphate suspension was orally administered twice a day, dose according to the label.
OTHER	Placebo for Oseltamivir phosphate dry suspension:	Drug: Placebo for Oseltamivir phosphate dry suspension: From Day1 to Day 5 : Placebo for Oseltamivir phosphate suspension was orally administered twice a day, dose according to the label.

Timeline

• Start date: 2024-10-31
• Primary completion: 2025-07-15
• Completion: 2025-07-15
• First posted: 2024-11-01
• Last updated: 2025-08-13

Locations

3 sites across 1 country: China