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

Zenshine Pharmaceuticals

Status and phase: Completed; Phase 3; Phase 2

Conditions: Influenza, Human

Treatments: Drug: ZX-7101A

Study type: Interventional

Funder types: Industry

Identifiers

NCT05702489

ZX-7101A-202

Details and patient eligibility

About

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.

Enrollment: 900 patients

Sex: All

Ages: 18 to 64 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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900 participants in 3 patient groups, including a placebo group

ZX-7101A low dose group

Experimental group

Description:

40 mg, tablet, single oral administration when the subject screened successfully

Treatment:

Drug: ZX-7101A

ZX-7101A high dose group

Experimental group

Description:

80 mg, tablet, single oral adminitration when the subject screened successfully

Treatment:

Drug: ZX-7101A

Placebo control

Placebo Comparator group

Description:

Analog tablet with no active ingredient, single oral administration when the subject screened successfully

Treatment:

Drug: ZX-7101A