NCT06099873

Study to Assess the Safety and Efficacy of ZX-7101A in Adolescents With Influenza

A Multicenter, Randomized, Double-blind, Placebo-controlled Phase III Trial of ZX-7101A Tablets to Evaluate the Efficacy and Safety in the Treatment of Uncomplicated Influenza in Adolescents

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 361 (actual)
• Sponsor: Nanjing Zenshine Pharmaceuticals · Industry
• Sex: All
• Age: 12 Years – 17 Years
• Healthy volunteers: Not accepted

Summary

The primary object of this study is evaluating the efficacy of ZX-7101A tablets versus placebo in the treatment of uncomplicated simple influenza in adolescents. The seongdary object is evaluating the safety of ZX-7101A tablet in the treatment of uncomplicated simple influenza in adolescents.

Detailed description

In this study, adolescents aged 12 and \< 18 with uncomplicated influenza are selected as subjects. Typical systemic and/or respiratory influenza symptoms were required, and the time interval between the first onset of influenza symptoms and random enrollment was less than 48 hours. This study is divided into screening/treatment period (D1) and observation period (about 2 weeks). You will be eligible before starting study therapy on day 1 (D1). Participants were randomly assigned 1:1 to ZX-7101A group (dose 40 mg, administration once) or placebo group (dose 1 placebo tablet, administration once), with 180 participants planned to be included in each group, for a total of about 360 participants.

Conditions

• Respiratory Viral Infection

Interventions

Type	Name	Description
DRUG	ZX-7101A	Day1 Take one tablet of ZX-7101A orally once (specification: 40mg/ tablet) with appropriate amount of warm water
DRUG	Placebo	Day1 Take one tablet of Placebo orally once with appropriate amount of warm water

Timeline

• Start date: 2023-11-30
• Primary completion: 2025-02-13
• Completion: 2025-02-13
• First posted: 2023-10-25
• Last updated: 2025-02-19

Locations

1 site across 1 country: China