Study to Assess the Safety and Efficacy of ZX-7101A for Oral Suspension in Chinese Pediatric Participants 2 to 11 Years of Age With Influenza

NCT07095257 | Completed Phase 3

• 1 other identifier: ZX-7101A-214
• Study Type: interventional
• Target: 169
• Locations: 1 country
• Sites: 2

Brief Summary

The goal of this phase III study is to learn if ZX-7101A for oral suspension works to treat uncomplicated influenza in Pediatric Participants aged 2 to 11 years. The main question it aims to answer is: What medical problems do participants have when taking drug ZX-7101A for oral suspension or Oseltamivir phosphate for oral suspension? Researchers will compare drug ZX-7101A for oral suspension to active comparator: Oseltamivir phosphate for oral suspension to see if drug ZX-7101A for oral suspension works to treat uncomplicated influenza in Pediatric Participants aged 2 to 11 years.

Conditions

Respiratory Viral Infection

Outcome Measures

Primary Outcomes (1)

• 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, physical examination, and Laboratory test compared with the baseline.

  From day1 up to day15

Secondary Outcomes (8)

• Time to Alleviation of Influenza Signs and Symptoms

  From day1 up to day15

• Duration of fever

  From day1 up to day15

• Time to Alleviation of Symptoms

  From day1 up to day15

• Time to Return to Normal Health and Activity

  From day1 up to day15

• The time influenza RNA turns negative

  From day1 up to day15

Study Arms (2)

ZX-7101A for oral suspension

EXPERIMENTAL

A randomized phase III study with safety as primary endpoint was conducted in children (2-11 years old) with uncomplicated influenza. Eligible subjects were randomly assigned in a 2:1 ratio to receive either ZX-7101A for oral suspension （specification：10mg per bag）or oseltamivir phosphate for oral suspension （specification：0.36 g）. Preparation of suspension solution ZX-7101A: the specification of the dry suspension is 10 mg per bag. Add 10 ml of warm water for each bag, Mix well and take it all at once as soon as possible. Administer the dosage according to body weight.

Drug: ZX-7101A for oral suspension

Oseltamivir phosphate for oral suspension

ACTIVE COMPARATOR

A randomized phase III study with safety as primary endpoint was conducted in children (2-11 years old) with uncomplicated influenza. Eligible subjects were randomly assigned in a 2:1 ratio to receive either ZX-7101A for oral suspension （specification：10mg per bag）or oseltamivir phosphate for oral suspension （specification：0.36 g）. Administer the medication according to the weight specified in the label.

Drug: Oseltamivir phosphate for oral suspension

Interventions

ZX-7101A for oral suspension DRUG

ZX-7101A will be administered as oral suspension in a single dose on Day 1. Oseltamivir phosphate matching placebo will also be administered as oral suspension twice daily (BID) for 5 days.

ZX-7101A for oral suspension

Oseltamivir phosphate for oral suspension DRUG

Oseltamivir phosphate will be administered as oral suspension BID for 5 days. Participants receiving oseltamivir will also receive ZX-7101A matching placebo as oral suspension, single dose on Day 1.

Oseltamivir phosphate for oral suspension

Eligibility Criteria

• Age: 2 Years - 11 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• ≥2 to\<12 years of age at the time of randomization, males or females.
• Patients in the screening period met the following criteria:
• Rapid influenza diagnostic test (RIDT) or polymerase chain reaction (PCR) test positive;
• Axillary temperature ≥ 37.5℃ at screening; If taking antipyretics, axillary temperature ≥ 37.5℃ after taking the drug (more than 4 hours).
• At least one of the influenza-related respiratory symptoms is moderate or greater in severity: nasal congestion/runny nose and coughing.
• The first occurrence of influenza symptoms ≤ 48 hours from the time of patient randomization. The occurrence of symptoms is defined as:
• The body temperature first reached ≥ 37.5℃ (axillary/oral temperature) or 38.0℃ (rectal or tympanic temperature);
• Or the occurrence of at least one systemic or respiratory symptom: nasal congestion, sore throat, cough, muscle pain, headache, etc.
• The guardian of the participants must agree to participate in the study and sign a written informed consent form. For participants aged 8 years old and above, they must sign the informed consent form voluntarily (for participant under the age of 8, only the informed consent form signed by the guardian is required.); The participant s and/or their guardians agree to comply with all study procedures, including filling out the participant diary cards (the guardians of the subjects may assist in the assessment/filling).

You may not qualify if:

• Patients with severe or critically influenza virus infection (Meet any one of the following criteria).
• Severe cases with any of the following conditions： Dyspnea and/or increased respiratory rate: more than 30 breaths per minute for children over 5 years old; over 40 times per minute for children aged 2 to 5.
• Changes in consciousness: slow response, drowsiness, restlessness, convulsions, etc.
• Severe vomiting or diarrhea, with signs of dehydration. oliguria: Children with urine output\<0.8 mL/(kg · h), or infants with daily urine output\<200 mL/m2, preschool children\<300 mL/m2, school aged children\<400 mL/m2, or experiencing renal failure;
• Critical cases with any of the following conditions (Including but not limited to)： Respiratory failure; Acute necrotizing encephalomyopathy; Shock septic; Multiple organ dysfunction; Other serious clinical situations require intensive care Note: Refer to \<the Expert Consensus on Diagnosis and Treatment of Childhood Influenza (2020 Edition)\>
• High risk population for severe cases (meeting any of the following criteria):
• Accompanied by the following underlying diseases, and being clinically significant according to researchers' judgment, such as lung diseases (asthma, tracheopulmonary dysplasia, cystic fibrosis, etc.), liver diseases, kidney diseases, hematological diseases, heart diseases (congenital heart disease, chronic congestive heart failure \[NYHA heart function classification III-IV\], etc. But excluding hypertension without any other heart related symptoms), neurological and neuromuscular diseases that affect respiratory secretion clearance function (cognitive impairment, spinal cord injury, epileptic seizures, neuromuscular disorders, and cerebral palsy, etc), metabolic and endocrine system diseases.
• Immunocompromised individuals, such as patients with malignant tumors, organ or bone marrow transplants, HIV infections, or those who have been taking immunosuppressive drugs in the past 3 months.
• The electrocardiogram shows clinically significant QT corrected interval abnormalities (QTc ≥ 460ms) (QT corrected interval calculated according to Fridericia's formula, i.e. QTcF).
• Subjects require long-term use of aspirin or salicylate containing defined as those who need to take aspirin or salicylate containing drugs regularly per day for more than 14 days.
• With a body mass index (BMI) exceeding the criteria outlined in Appendix 2 of this protocol; During the screening period, patients with clinically significant bronchitis, pneumonia, pleural effusion, or interstitial lesions that identified by the researchers. If the researcher deems it necessary, imaging examinations (chest X-ray or chest CT) can be performed.
• Individuals who have experienced acute respiratory infections or otitis media and sinusitis within the past 2 weeks prior to screening.
• Combined with other respiratory infections, or requiring systemic anti infection treatment, or blood routine examination during screening with white blood cell count (WBC)\>ULN (venous blood).
• Coughing up purulent phlegm or suffering from purulent tonsillitis.
• Have difficulty in swallowing medicine or have a history of gastrointestinal diseases that determined by researchers to seriously affect drug absorption.

Sponsors & Collaborators

• Nanjing Zenshine Pharmaceuticals: lead

Study Sites (2)

West China Second University Hospital, Sichuan University

Chengdu, Sichuan, China

Location

Children's Hospital Zhejiang University School of Medicine

Hangzhou, Zhejiang, China

Location

MeSH Terms

Interventions

Suspensions; Oseltamivir

Intervention Hierarchy (Ancestors)

Colloids; Complex Mixtures; Dosage Forms; Pharmaceutical Preparations; Acetamides; Amides; Organic Chemicals; Cyclohexenes; Cyclohexanes; Cycloparaffins; Hydrocarbons, Alicyclic; Hydrocarbons, Cyclic; Hydrocarbons

Study Design

• Study Type: interventional
• Phase: phase 3
• 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: July 24, 2025
• First Posted: July 31, 2025
• Study Start: October 13, 2025
• Primary Completion: January 16, 2026
• Study Completion: January 16, 2026
• Last Updated: April 16, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

CN (2)