This is a multicenter, randomized, double-blind, placebo-controlled Phase II study to evaluate the efficacy and safety of SYH2085 tablets compared with placebo in Chinese adult participants with uncomplicated influenza. The study plans to enroll patients with typical systemic and respiratory influenza symptoms, with symptom onset ≤48 hours.
Age ≥18 years at time of signing ICF.
Positive influenza antigen test or influenza virus nucleic acid test (other rapid molecular diagnostic methods are acceptable).
Axillary temperature ≥37.3°C at screening; if antipyretics have been taken, axillary temperature ≥37.3°C at least 4 hours after dosing;
At least one systemic influenza symptom of moderate or greater severity: muscle/joint aches, fatigue, headache, fever/chills;
Significant exacerbation of underlying diseases, e.g., COPD, diabetes, chronic heart failure, chronic renal failure, cirrhosis, etc.
Respiratory rate ≥30/min;
Oxygen saturation ≤93% on room air at rest;
PaO2/FiO2 ≤300; for high-altitude areas (>1000 m), correction: PaO2/FiO2 × [760/atmospheric pressure (mmHg)] (1 mmHg=0.133 kPa);
Parallel
SYH2085
DrugOne or two 40-mg SYH2085 tablets taken orally
Placebo
DrugOne or two placebo tablets taken orally
Time to resolution of all influenza symptoms (hours)
Time to resolution of all influenza symptoms (hours) is defined as the time from start of study treatment to resolution of all influenza symptoms. Resolution of all influenza symptoms. is defined as all 7 influenza symptoms (headache, fever/chills, muscle/joint aches, fatigue, cough, nasal congestion, sore throat) rated as 2 or 3 becoming 0 (absent) or 1 (mild), and all clinical symptoms rated as 0 or 1 remaining resolved; with duration of resolution at least 21.5 hours (approximately 24 hours minus 10%).
Time to influenza virus RNA negativity (hours)
Time to influenza virus RNA negativity (hours) is defined as time from start of study treatment to first influenza virus RNA below the lower limit of detection (by RT-PCR).
Time to influenza virus titer negativity (hours)
Time to influenza virus titer negativity (hours) is defined as time from start of study treatment to first virus titer below the lower limit of quantification.
Change from baseline in influenza virus RNA (log10 copies/mL) at each visit
Nasopharyngeal swabs will be collected from participants at the study center and sent to the central laboratory for quantitation of viral RNA load.
Change from baseline in influenza virus and virus titer (log10 TCID50/mL) at each visit
Nasopharyngeal swabs will be collected from participants at the study center and sent to the central laboratory for quantitation of viral titer.
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