Study of ZSP1273 in Patients With Acute Uncomplicated Influenza A

This is an interventional treatment trial for Influenza A Read More

Inclusion Criteria:

1. Males and female subjects between 18-65 years (Both inclusive).

2. Patients with a diagnosis of influenza virus A infection confirmed by all of the following:

   • Positive Rapid Antigen Test (RAT) with throat swabs;and
   • Fever≥38.0ºC (axillary) in the predose examinations;and

   • At least one of the following general systemic symptoms and respiratory symptoms respectively associated with influenza are present with a severity of moderate or greater:

     • General systemic symptoms:Headache,Feverishness or chills,Muscle or joint pain,Fatigue;
     • Respiratory symptoms:Cough,Sore throat,Nasal congestion.

3. The time interval between the onset of symptoms and the enrollment is≤48 hours. The onset of symptoms is defined as:

   • Time of the first increase in body temperature(axillary temperature≥38.0ºC),or
   • Time when the patient experiences at least one general or respiratory symptom.
4. Subjects who agree to use an appropriate method of contraception during the study and up to 6 months after drug withdrawal.
5. Signature of a dated Informed Consent Form (ICF) indicating that the subject has been informed of all the relevant aspects(including adverse events) of the trial prior to enrollment.

Exclusion Criteria:

1. Known hypersensitivity and/or allergy to some drugs and food,especially for the composition that is similar to ZSP1273;
2. Dysphagia or any medical history in gastrointestinal that interferes with the absorption of drugs.

3. Use of the following medications within 7 days prior to screening:

   • Influenza antiviral medication:oseltamivir,peramivir,famivir,abidol,amantadine or rimantadine.
   • Chinese patent medicine or herbal medicine with antiviral effect.
4. Patients who have received influenza vaccine within 6 months prior to enrollment.
5. Presence of clinically significant abnormalities in ECG .
6. Chest X - ray examination confirmed bronchitis,pneumonia,pleural effusion or pulmonary interstitial lesions.
7. Patients who have experienced respiratory tract infection,Otitis media,nasosinusitis.
8. White blood cells(WBC)>10.0×109/L at screening.
9. Subject who produces purulent sputum or has suppurative tonsillitis.
10. Patients with severe or uncontrollable underlying diseases:blood disorders,severe chronic obstructive pulmonary disease(COPD),liver disorders(ALT or AST≥3 ULN,total bilirubin≥1.5 ULN),kidney disorders(serum creatinine>177μmol/L or 2mg/dL),chronic congestive heart failure(NYHA III-IV),mental disorders.
11. Immunodeficiency,including malignant tumor,organ or marrow transplant,human immunodeficiency virus [HIV] infection,or patients receiving immunosuppressant therapy 3 months prior to enrollment.
12. Concomitant therapy with aspirin or salicylic acid.
13. Morbid obesity(Body mass index [BMI]≥30kg/m2).
14. Known history of alcohol abuse or drug abuse.
15. Pregnancy or breastfeeding at screening and during the study.All female subjects of childbearing potential must have a negative urine pregnancy test at screening and during the trial.
16. Have received any other investigational products within 3 months prior to dosing.
17. Subjects who should not be included in the study in the opinion of the Investigator.