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

Sponsor
Nanjing Zenshine Pharmaceuticals (Industry)
Overall Status
Recruiting
CT.gov ID
NCT05702489
Collaborator
(none)
210
Enrollment
1
Location
3
Arms
21.4
Anticipated Duration (Months)
9.8
Patients Per Site Per Month

Study Details

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.

Condition or Disease Intervention/Treatment Phase
Phase 2/Phase 3

Study Design

Study Type:
Interventional
Anticipated Enrollment :
210 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Double (Participant, Investigator)
Primary Purpose:
Treatment
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
Actual Study Start Date :
Sep 17, 2022
Anticipated Primary Completion Date :
Dec 31, 2023
Anticipated Study Completion Date :
Jun 30, 2024

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

  1. The time to the remission of all influenza symptoms (hours) [from accepting ZX-7101A until the 15 days after the first dosing]

    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

  1. Number of Participants with Treatment-Related Adverse Events as Assessed by CTCAE v5.0 [from accepting ZX-7101A until the 15 days after the first dosing]

    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.

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 64 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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.

Contacts and Locations

Locations

Site City State Country Postal Code
1 Zhongshan Hospital Affiliated to Fudan University Shanghai China

Sponsors and Collaborators

  • Nanjing Zenshine Pharmaceuticals

Investigators

  • Principal Investigator: hong wen Zhang, doctor, Huashan Hospital

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Nanjing Zenshine Pharmaceuticals
ClinicalTrials.gov Identifier:
NCT05702489
Other Study ID Numbers:
  • ZX-7101A-202
First Posted:
Jan 27, 2023
Last Update Posted:
Jan 27, 2023
Last Verified:
Jan 1, 2023
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:
Influenza, Human

Study Results

No Results Posted as of Jan 27, 2023