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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2/PHASE3

Total Enrollment

900 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-07-17

Study Completion Date

2023-10-13

Brief Summary

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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.

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Detailed Description

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Conditions

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Influenza, Human

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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ZX-7101A low dose group

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

Group Type EXPERIMENTAL

ZX-7101A

Intervention Type DRUG

a drug to treatment influenza in Chinese adults

ZX-7101A high dose group

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

Group Type EXPERIMENTAL

ZX-7101A

Intervention Type DRUG

a drug to treatment influenza in Chinese adults

Placebo control

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

Group Type PLACEBO_COMPARATOR

ZX-7101A

Intervention Type DRUG

a drug to treatment influenza in Chinese adults

Interventions

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ZX-7101A

a drug to treatment influenza in Chinese adults

Intervention Type DRUG

Eligibility Criteria

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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.

Minimum Eligible Age

18 Years

Maximum Eligible Age

64 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No