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

A Multicenter, Randomized, Double-Blind, Placebo-Controlled, Phase 2/3 Study to Evaluate the Efficacy and Safety of ZX-7101A Tablets in Adults with Uncomplicated Influenza

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.

Study Overview

• Status: Completed
• Conditions: Influenza, Human
• Intervention / Treatment: Drug: ZX-7101A

• Study Type: Interventional
• Enrollment (Actual): 900
• Phase: Phase 2; Phase 3

Contacts and Locations

Study Locations

• China
  • Shanghai, China
    • Zhongshan Hospital Affiliated to Fudan University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 64 years (Adult)
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: ZX-7101A low dose group; 40 mg, tablet, single oral administration when the subject screened successfully	Drug: ZX-7101A; a drug to treatment influenza in Chinese adults
Experimental: ZX-7101A high dose group; 80 mg, tablet, single oral adminitration when the subject screened successfully	Drug: ZX-7101A; a drug to treatment influenza in Chinese adults
Placebo Comparator: Placebo control; Analog tablet with no active ingredient, single oral administration when the subject screened successfully	Drug: ZX-7101A; a drug to treatment influenza in Chinese adults

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
The time to the remission of all influenza symptoms (hours)	Defined as the time from the start of study treatment to the time all flu symptoms are relieved. Symptom relief was defined as all seven influenza symptoms assessed by the subject on the subject diary card(Stuffy nose, sore throat, cough, muscle or joint pain, fatigue, headache, fever or chills/sweating) were 0 (asymptomatic) or 1 (mild);	from accepting ZX-7101A until the 15 days after the first dosing

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of Participants with Treatment-Related Adverse Events as Assessed by CTCAE v5.0	The Number of Participants with Treatment-Related Adverse Event will be evalated as the change of vital signs, electrocardiogram (P Wave, QRS Complex, QT Interval), physical examination, and Laboratory test compared with the baseline.	from accepting ZX-7101A until the 15 days after the first dosing

Collaborators and Investigators

• Sponsor: Nanjing Zenshine Pharmaceuticals
• Investigators: Principal Investigator: hong wen Zhang, doctor, Huashan Hospital

Study record dates

Study Major Dates

• Study Start (Actual): July 17, 2022
• Primary Completion (Actual): May 26, 2023
• Study Completion (Actual): October 13, 2023

Study Registration Dates

• First Submitted: January 16, 2023
• First Submitted That Met QC Criteria: January 25, 2023
• First Posted (Actual): January 27, 2023

Study Record Updates

• Last Update Posted (Estimated): November 5, 2024
• Last Update Submitted That Met QC Criteria: November 3, 2024
• Last Verified: November 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Respiratory Tract Infections; Infections; Orthomyxoviridae Infections; RNA Virus Infections; Virus Diseases; Respiratory Tract Diseases; Influenza, Human
• Other Study ID Numbers: ZX-7101A-202

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No