NCT05474755

To Assess the Efficacy of GP681 Tablet Versus Placebo in Patients With Acute Uncomplicated Influenza Virus Infection

A Multi-center, Randomized, Double-blind, Placebo-controlled Phase III Clinical Study on the Safety and Efficacy of GP681 Tablets in the Treatment of Acute Uncomplicated Influenza

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 591 (actual)
• Sponsor: Jiangxi Qingfeng Pharmaceutical Co. Ltd. · Industry
• Sex: All
• Age: 5 Years – 65 Years
• Healthy volunteers: Not accepted

Summary

This study will evaluate the efficacy, safety, and population pharmacokinetics of a single, oral dose of GP681 compared with placebo in patients aged 12 to 65 years with acute uncomplicated influenza virus infection

Conditions

• Influenza

Interventions

Type	Name	Description
DRUG	GP681 40mg	2X20mg tablets taken orally
DRUG	Placebo	Placebo tablets matching GP681 40mg

Timeline

• Start date: 2022-07-28
• Primary completion: 2023-04-25
• Completion: 2023-10-31
• First posted: 2022-07-26
• Last updated: 2023-11-14

Locations

1 site across 1 country: China