Jiangxi Qingfeng Pharmaceutical Co. Ltd.

Index patients who are infected with influenza virus (Q-PCR positive) can be treated with anti-influenza drugs if their influenza symptoms onset was within 48 hours of screening. Their eligible households will be randomized to either GP681 tablets or placebo if at least 1 household contacts have not received influenza vaccine with 6 months of screening and if all household contacts screen negative for influenza infection. The main endpoints are assessed based on multiple respiratory swabs, obtained from household contacts up to Day 10, and through the assessment of symptoms.

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.

1)评估单次口服GP681干混悬剂在治疗无并发症的单纯性流感儿童及青少年患者(2至<18周岁)中的耐受性与安全性； 2)研究GP681干混悬剂在无并发症的单纯性流感儿童及青少年患者(2至<18周岁)中的药代动力学(PK)特征； 3)评估单次口服GP681干混悬剂在治疗无并发症的单纯性流感儿童及青少年患者(2至<18周岁)中的有效性，探索确证性临床试验的最佳剂量。