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

Primary Purpose

Influenza, Human

Status
Recruiting
Phase
Phase 2
Locations
China
Study Type
Interventional
Intervention
ZX-7101A
Sponsored by
Nanjing Zenshine Pharmaceuticals
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Influenza, Human

Eligibility Criteria

18 Years - 64 Years (Adult)All SexesDoes not accept 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.

Sites / Locations

  • Zhongshan Hospital Affiliated to Fudan UniversityRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Experimental

Placebo Comparator

Arm Label

ZX-7101A low dose group

ZX-7101A high dose group

Placebo control

Arm Description

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

Outcomes

Primary Outcome Measures

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);

Secondary Outcome Measures

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.

Full Information

First Posted
January 16, 2023
Last Updated
January 25, 2023
Sponsor
Nanjing Zenshine Pharmaceuticals
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1. Study Identification

Unique Protocol Identification Number
NCT05702489
Brief Title
A Study to Evaluate the Efficacy and Safety of ZX-7101A Tablets in Adults With Uncomplicated Influenza
Official Title
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
Study Type
Interventional

2. Study Status

Record Verification Date
January 2023
Overall Recruitment Status
Recruiting
Study Start Date
September 17, 2022 (Actual)
Primary Completion Date
December 31, 2023 (Anticipated)
Study Completion Date
June 30, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Nanjing Zenshine Pharmaceuticals

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Influenza, Human

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2, Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
210 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
ZX-7101A low dose group
Arm Type
Experimental
Arm Description
40 mg, tablet, single oral administration when the subject screened successfully
Arm Title
ZX-7101A high dose group
Arm Type
Experimental
Arm Description
80 mg, tablet, single oral adminitration when the subject screened successfully
Arm Title
Placebo control
Arm Type
Placebo Comparator
Arm Description
Analog tablet with no active ingredient, single oral administration when the subject screened successfully
Intervention Type
Drug
Intervention Name(s)
ZX-7101A
Intervention Description
a drug to treatment influenza in Chinese adults
Primary Outcome Measure Information:
Title
The time to the remission of all influenza symptoms (hours)
Description
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);
Time Frame
from accepting ZX-7101A until the 15 days after the first dosing
Secondary Outcome Measure Information:
Title
Number of Participants with Treatment-Related Adverse Events as Assessed by CTCAE v5.0
Description
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.
Time Frame
from accepting ZX-7101A until the 15 days after the first dosing

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
64 Years
Accepts Healthy Volunteers
No
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
hong Wen Zhang, doctor
Phone
5288123
Email
zhangwenhong202208@126.com
First Name & Middle Initial & Last Name or Official Title & Degree
Jing Zhang, doctor
Phone
52887926
Email
Zhangj_fudan@163.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
hong wen Zhang, doctor
Organizational Affiliation
Huashan Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Zhongshan Hospital Affiliated to Fudan University
City
Shanghai
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
bi jie Hu, Doctoral candidate
Phone
13601621604
Email
hu.bijie@zs-hospital.sh.cn

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

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

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