A Study to Evaluate the Efficacy and Safety of ZX-7101A Tablets in Adults With Uncomplicated Influenza

• Status: Recruiting
• Trial end date: 2024-06-30
• Target enrollment: 0
• Participant gender: All

Summary

The goal of this clinical trial is to compare ZX-7101A in Chinese Adults patients with uncomplicated influenza. The main questions it aims to answer are:

• The efficacy of ZX-7101A in Chinese Adults patients with uncomplicated influenza.

• The safety of ZX-7101A in Chinese Adults patients with uncomplicated influenza.

• Phase: Phase 2/Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Nanjing Zenshine Pharmaceuticals

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.