Study to Assess the Safety and Efficacy of ZX-7101A in Children Aged 5-11 Years with Influenza

Inclusion Criteria:

• 1.≥5 to<12 years of age at the time of randomization, males or females.

• 2.Patients in the screening period met the following criteria:

1. Rapid influenza diagnostic test (RIDT) or polymerase chain reaction (PCR) testpositive;

2. Axillary temperature ≥ 37.5℃ at screening; If taking antipyretics, axillarytemperature ≥ 37.5℃ after taking the drug (more than 4 hours).

3. At least one of influenza -related systemic symptoms is moderate or greater inseverity: a. muscle or joint pain, b. fatigue, c. headache, d. fever.

4. At least one of the influenza-related respiratory symptoms is moderate orgreater in severity: a. nasal congestion, b. sore throat, c. cough.

3. The first occurrence of influenza symptoms ≤ 48 hours from the time of patientrandomization.

4. Body temperature ≥ 37.5 ℃ (axillary temperature) or 37.5 ℃ (oral temperature)or 38.0 ℃ (rectal or tympanic membrane temperature)for the first time;

5. Or at least one systemic or respiratory symptom may occur: a. nasal congestion,b. sore throat, c. cough, d. muscle or joint pain, e. fatigue, f. headache, g.fever.

4. Both the subject and his/her guardian are volunteer to participate in the studyand sign the written informed consent form (ICF), the subject could comply withall the study procedures, complete the subject diary as required (the guardianis allowed to fill in if necessary).

Exclusion Criteria:

• Patients with severe influenza virus infection requiring inpatient treatment. (Meetany one of the following criteria)

1. Severe cases with one of the following conditions：

• Persistent high fever for more than 3 days, accompanied by severe cough,purulent sputum, bloody sputum, or chest pain;
• Fast breathing rate, difficulty breathing, cyanosis of lips;
• Delayed response, drowsiness, restlessness, and other mental changes orseizures;
• Severe vomiting, diarrhea, and dehydration symptoms;
• Concomitant pneumonia;
• Significant exacerbation of existing underlying diseases;
• Other clinical situations that require hospitalization.

2. Critical cases with one of the following conditions (Including but not limitedto)：

• Respiratory failure;

• Acute necrotizing encephalopathy;

• Shock;

• Multiple organ dysfunction;

• Other serious clinical situations that require monitoring and treatment.

2. High risk population for severe cases. (Meet any one of the followingcriteria):

3. Accompanied by the following basic diseases and judged by the investigators tobe clinically significant, such as lung diseases, liver diseases, kidneydiseases, hematological system diseases, heart diseases, neurological andneuromuscular diseases that affect the ability to clear respiratory secretions,metabolic and endocrine system diseases, etc;

4. Subjects with low immune function, such as malignant tumors, organ or bonemarrow transplants, HIV infections, or those who have been takingimmunosuppressants for the past 3 months;

5. Clinical significance of correcting QT interval abnormalities inelectrocardiogram display; (QTc>440ms in male or QTc>450ms in female);

6. Subjects who require long-term use of drugs containing aspirin or salicylates :It is necessary to take medication containing aspirin or salicylate regularlyevery day for more than 14 days;

7. BMI exceeds the standards.

3. Bronchitis, pneumonia, pleural effusion or interstitial disease confirmed bychest imaging [X-ray (anteroposterior or anteroposterior) /CT] and judgedclinically significant by the investigator at screening.

4. Subjects who have developed acute respiratory tract infection, otitis media,and sinusitis within 2 weeks before screening.

5. Subjects with other respiratory infections requiring systemic anti-infectivetreatment, or blood routine examination at screening: white blood cell count (WBC) > (venous blood)

6. Subjects with purulent sputum or suppurative tonsillitis.

7. Have difficulty in swallowing drugs or have a history of gastrointestinaldiseases that seriously affect drug absorption (including but not limited toreflux esophagitis, chronic diarrhea, inflammatory bowel disease, intestinaltuberculosis, gastrinoma, short bowel syndrome, subtotal gastrectomy, etc.).

8. Suspected allergic to active ingredients or excipients of the investigationalproduct.

9. Body weight < 20 kg.

10. Medications against influenza virus within 7 days before screening (includingbut not limited to: neuraminidase inhibitors, hemagglutinin inhibitors, M2 ionchannel blockers, and cap structure inhibitors. Lysine endonuclease (CEN)inhibitors, such as oseltamivir, zanamivir, peramivir, favipiravir,rimantadine, amantadine, abidol, baloxavir, etc.).

11. Have received live vaccines or attenuated live vaccines within 14 days beforerandomization, influenza vaccines within 6 months before randomization.

12. Suspected or confirmed a history of alcohol or drug abuse.

13. Ppregnancy test was positive

14. Participants who participated in another clinical trial and used any otherinvestigational drug or device within 30 days before screening.

15. Subjects judged by the investigator to be ineligible for participation in thestudy.