A Study to Evaluate the Efficacy and Safety of ZX-7101A Tablets in Adults With Uncomplicated Influenza
Influenza, Human
About this trial
This is an interventional treatment trial for Influenza, Human
Eligibility Criteria
Inclusion Criteria: ≥18 to ≤64 years of age at the time of signing the ICF. Patients in the screening period met the following criteria: (1) rapid influenza diagnostic test (RIDT) or polymerase chain reaction (PCR) test positive; (2) fever ≥ 37.3℃ (axillary temperature) at screening; if taking antipyretics, axillary temperature ≥ 37.3℃ after taking the drug (more than 4 hours). (3) At least one of flu-related systemic symptoms is moderate or greater in severity: a. muscle or joint pain, b. fatigue, c. headache, d. fever. (4) At least one of the influenza-related respiratory symptoms is moderate or greater in severity: a. nasal congestion, b. sore throat, c. cough. The first occurrence of influenza symptoms ≤ 48 hours from the time of patient randomization. Exclusion Criteria: Patients with influenza virus infection requiring hospitalization. High-risk population. Bronchitis, pneumonia, pleural effusion or interstitial disease suspected by a clinician or confirmed by chest imaging [X-ray (anteroposterior or anteroposterior)/CT] and judged clinically significant by the investigator at screening. Patients who have developed acute respiratory tract infection, otitis media, and sinusitis within 2 weeks before screening. Patients with other infections requiring systemic anti-infective treatment, or blood routine examination at screening: white blood cell count (WBC) > 10.0 × 109/L. Patients with purulent sputum or suppurative tonsillitis. Those who have difficulty in swallowing drugs or have a history of gastrointestinal diseases that seriously affect drug absorption. Medications against influenza virus within 7 days prior to Screening.
Sites / Locations
- Zhongshan Hospital Affiliated to Fudan UniversityRecruiting
Arms of the Study
Arm 1
Arm 2
Arm 3
Experimental
Experimental
Placebo Comparator
ZX-7101A low dose group
ZX-7101A high dose group
Placebo control
40 mg, tablet, single oral administration when the subject screened successfully
80 mg, tablet, single oral adminitration when the subject screened successfully
Analog tablet with no active ingredient, single oral administration when the subject screened successfully