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

NCT05702489 | Completed Phase 2

• 1 other identifier: ZX-7101A-202
• Study Type: interventional
• Target: 900
• Locations: 1 country
• Sites: 1

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.

Conditions

Influenza, Human

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (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

Study Arms (3)

ZX-7101A low dose group

EXPERIMENTAL

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

Drug: ZX-7101A

ZX-7101A high dose group

EXPERIMENTAL

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

Drug: ZX-7101A

Placebo control

PLACEBO COMPARATOR

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

Drug: ZX-7101A

Interventions

ZX-7101A DRUG

a drug to treatment influenza in Chinese adults

Placebo control; ZX-7101A high dose group; ZX-7101A low dose group

Eligibility Criteria

• Age: 18 Years - 64 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• ≥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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Nanjing Zenshine Pharmaceuticals: lead

Study Sites (1)

Zhongshan Hospital Affiliated to Fudan University

Shanghai, China

Location

MeSH Terms

Conditions

Influenza, Human

Condition Hierarchy (Ancestors)

Respiratory Tract Infections; Infections; Orthomyxoviridae Infections; RNA Virus Infections; Virus Diseases; Respiratory Tract Diseases

Study Officials

• hong wen Zhang, doctor

  Huashan Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 16, 2023
• First Posted: January 27, 2023
• Study Start: July 17, 2022
• Primary Completion: May 26, 2023
• Study Completion: October 13, 2023
• Last Updated: November 5, 2024

Record last verified: 2024-11

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)