| Eligibility |
Inclusion Criteria:
1. Patients aged 18 to 65 years (including the cut-off point, Phase II) or 12 to 65 years
(including the cut-off point, Phase III) with a body weight = 20 kg, both sex;
2. Patients were diagnosed with Influenza A Virus Infection/Influenza B Virus Infection
according to the following criteria: nasopharyngeal swab or oropharyngeal swab was
positive under influenza rapid antigen test (RAT) (rapid influenza virus nucleic acid
test or other rapid molecular diagnostic methods are also acceptable); and fever (ear
temperature = 37.3°C or axillary temperature = 37.2°C), if taking antipyretics, ear
temperature = 37.3°C or axillary temperature = 37.2°C after 4 hours taking
antipyretics; at least one of the following symptoms are moderate or above (influenza
symptom severity score = 2) related to influenza: systemic symptoms: headache, fever
or chills, muscle or joint aches, fatigue; respiratory symptoms: cough, sore throat,
nasal congestion;
3. The time interval from the onset time of influenza to screening start = 48 hours.
Definition of influenza onset: the fever (ear temperature =37.3°C or axillary
temperature =37.2°C or oral temperature =37.7°C) (ear temperature, axillary
temperature and oral temperature measurements are acceptable), or the onset of any
systemic symptoms or respiratory symptoms related to influenza;
4. Fertile subjects (including their partners) agree to take effective contraceptive
methods throughout the study period and 3 months after study.
5. Voluntary participation in this clinical study and signing of the informed consent.
Exclusion Criteria:
1. Patients with known allergies to the test preparation, any of its components or
related preparations (or severe allergic constitution), and who are judged by the
investigator to have a safety risk for enter the trial;
2. Patients diagnosed as severe/critical flu at screening, as defined below:
1. Severe cases are defined as those meeting one of the following conditions:
High fever over 3 days, accompanied by severe cough, expectoration, bloody
sputum, or chest pain; rapid breathing, dyspnea, and cyanosis of the lips; mental
changes such as slow response, drowsiness, restlessness, or convulsions; severe
vomiting, diarrhea, and dehydration; complicated with pneumonia; significant
exacerbation of the original underlying disease;
2. Critical cases are defined as those meeting one of the following conditions:
Respiratory failure; acute necrotizing encephalopathy; shock; multiple organ
dysfunction;
3. High-risk population in severe cases are defined as those meeting any of the following
conditions, and who are judged by the investigator to have a safety risk in the trial:
Patients with severe or poorly controlled underlying diseases, such as chronic
respiratory diseases, liver diseases, chronic kidney diseases, severe hematological
diseases, chronic congestive heart failure [New York Heart Association (NYHA) cardiac
function classification III-IV], nervous system and neuromuscular diseases, metabolic
diseases, etc.; Subjects with clinically significant abnormalities in the corrected QT
interval (QTc> 450ms for males or QTc> 470ms for females) on electrocardiogram (QTcF
calculated according to the Fridericia formula); Subjects with immunodeficiency, such
as malignant tumor, organ or bone marrow transplantation, HIV infection, or taking
immunosuppressants in the past 3 months; Subjects with other diseases requiring
treatment with aspirin or salicylate drugs; Subjects with obesity [body mass index
(BMI) greater than 30 kg/m2].
4. Subjects with a known history of dysphagia or any gastrointestinal disease that
affects drug absorption (including but not limited to reflux esophagitis, chronic
diarrhea, inflammatory bowel disease, intestinal tuberculosis, gastrinoma, short bowel
syndrome, post-subtotal gastrectomy, etc.);
5. Subjects who had used anti-influenza virus drugs (oseltamivir, zanamivir, peramivir,
favipiravir, arbidol, baloxavir, amantadine or rimantadine, etc.) within 2 weeks
before screening or had received influenza vaccine within 6 months before screening;
6. Subjects with acute respiratory tract infection, otitis media, sinusitis or other
infectious diseases such as bronchitis, pneumonia, tuberculosis or other infectious
diseases within 2 weeks before screening;
7. Subjects with other bacterial or viral infections at the time of screening and need
systemic antibacterial or antiviral treatment, or subjects with blood routine test:
white blood cell count (WBC) > 10.0×109/L at the time of screening;
8. Pregnant or lactating women or positive pregnancy test. Pregnancy test is not required
for women who have stopped menstruation for more than 2 years, confirmed
postmenopausal women or women who have undergone hysterectomy, bilateral oophorectomy
or tubal ligation surgery;
9. Suspected or confirmed history of alcohol or drug abuse;
10. Those who have participated in other drug clinical trials within 3 months before
taking the drug;
11. Those who are not suitable for participation in the study in the judgment of the
investigator.
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