This study will evaluate the efficacy, safety, and population pharmacokinetics of a single, oral dose of GP681 compared with placebo in patients aged 12 and older With Influenza at High Risk of Influenza Complications.
Male or female patients aged ≥12 years at the time of signing the informed consent form.
Positive throat or nose swab by rapid influenza antigen test (RAT) (where rapid influenza virus nucleic acid test or other rapid molecular diagnostic methods are also acceptable);
Fever (axillary temperature ≥37.3℃) in the predose examinations or > 4 hours after dosing of antipyretics if they were taken;
Time of the first increase in body temperature (axillary temperature ≥37.3℃)
History of allergic reactions attributed to GP681,Acetaminophen, bromohexine hydrochloride or any of the ingredients of its formulation.
Known history of dysphagia or any gastrointestinal disease that affects drug absorption (including but not limited to chronic diarrhea, inflammatory bowel disease, tuberculosis of the intestines, gastrinoma, short bowel syndrome, postoperative gastrectomy, etc.);
Screening patients who, in the opinion of the investigator, require hospitalization due to severe influenza virus infection;.
Screening patients who, at the time of screening, are clinically diagnosed with bacterial or other viral infections requiring systemic antibacterial or antiviral treatment;