NCT06643156

Study to Assess the Tolerability, Safety and Efficacy of GP681 Powder for Oral Suspension

A Multicenter, Open-label, Single-arm, Exploratory Clinical Study on the Tolerability, Safety and Efficacy of GP681 Powder for Oral Suspension in the Treatment of Uncomplicated Influenza in Pediatric and Adolescent Patients

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 44 (actual)
• Sponsor: Jiangxi Qingfeng Pharmaceutical Co. Ltd. · Industry
• Sex: All
• Age: 2 Years – 18 Years
• Healthy volunteers: Not accepted

Summary

This study aims to evaluate the tolerability, safety, pharmacokinetic characteristics and efficacy of a single oral dose of GP681 powder for oral suspension in pediatric and adolescent patients with uncomplicated influenza. The study will also explore the optimal dose for a confirmatory clinical trial. Eligible patients who have been confirmed influenza virus infection and have experienced influenza symptoms within 48 hours prior to enrollment, will receive single dose of GP681 powder for oral suspension. The primary outcome measures included the observation of adverse events during the study, the pharmacokinetic parameters, as well as the efficacy endpoints including time to alleviation of influenza symptoms, viral clearance rate, changes in viral load, etc.

Conditions

• Influenza

Interventions

Type	Name	Description
DRUG	GP681 10mg/20mg/40mg	0.5/1/2×20mg power for oral suspension taken orally

Timeline

• Start date: 2024-09-27
• Primary completion: 2025-01-18
• Completion: 2025-01-18
• First posted: 2024-10-16
• Last updated: 2025-03-18

Locations

1 site across 1 country: China