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

Influenza, Human Clinical Trial

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05702489
• Other study ID #: ZX-7101A-202
• Status: Recruiting
• Phase: Phase 2/Phase 3
• Start date: September 17, 2022
• Est. completion date: June 30, 2024

Study information

• Verified date: January 2023
• Source: Nanjing Zenshine Pharmaceuticals
• Contact: hong Wen Zhang, doctor
• Phone: 5288123
• Email: zhangwenhong202208[@]126.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 210
• Est. completion date: June 30, 2024
• Est. primary completion date: December 31, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 64 Years

Eligibility

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.

Related Conditions & MeSH terms

• Influenza, Human

Intervention

Drug:
• ZX-7101A
a drug to treatment influenza in Chinese adults

Locations

Country	Name	City	State
China	Zhongshan Hospital Affiliated to Fudan University	Shanghai

Sponsors (1)

Lead Sponsor	Collaborator
Nanjing Zenshine Pharmaceuticals

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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