Respiratory Viral InfectionPhase 3ZX-7101A-214NCT07095257

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

A Phase 3 study testing ZX-7101A for oral suspension and Oseltamivir phosphate for oral suspension in people with Respiratory Viral Infection, run by Nanjing Zenshine Pharmaceuticals at 2 sites in China.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial 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… Read more about this study

Who is it for?: Ages 2 to 11 years
Conditions the study is for: Respiratory Viral Infection
What is being tested?: ZX-7101A for oral suspension and Oseltamivir phosphate for oral suspension
Type of treatment: Pill or oral medicine
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 169 participants
Where: 2 sitesChina
Study dates: 13 Oct 2025to 16 Jan 2026
Phase: Phase 3
Are there results?: None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 2 to 11 years
All sexes
No healthy volunteers
Child

Who may be able to join

≥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:

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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).

Who cannot join

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):

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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.
Suspected allergy to the active ingredients or excipients of the investigational drug.
Have taken anti influenza virus drugs (including but not limited to: neuraminidase inhibitors, hemagglutinin inhibitors, M2 ion channel blockers, and cap structure dependent endonuclease (CEN) inhibitors, such as oseltamivir, zanamivir, paramivir, favipiravir, rimantadine, amantadine, abiidol, balosavir, etc.) within the past 7 days prior to screening.
Received live or attenuated vaccines within the first 2 weeks of randomization or subjects who have received influenza vaccine within the first 2 weeks of randomization;
Suspect or have a history of alcohol or drug abuse.
Positive in pregnancy test.
Participated in other clinical trials and used any other clinical trial drugs or devices within the 30 days prior to screening;
Determined by the researchers to be unsuitable for participation in this clinical study.

Trial locations and contacts

2 sites in 1 country.

China2 sites

West China Second University Hospital, Sichuan University
Chengdu, Sichuan
Children's Hospital Zhejiang University School of Medicine
Hangzhou, Zhejiang

Other trials in China

About this study

Official title: A Multicenter, Randomized, Double-blind, Positive Controlled, Phase III Trial to Evaluate the Safety and Efficacy of ZX-7101A for Oral Suspension in Pediatric Participants Aged 2 to 11 With Influenza

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
Being tested: ZX-7101A for oral suspension, Oseltamivir phosphate for oral suspension

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

ZX-7101A for oral suspensionDrug
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.
Oseltamivir phosphate for oral suspensionDrug
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.

Study groups in NCT07095257
Study group	Role	What they receive
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. Receives: 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. Receives: Drug: Oseltamivir phosphate for oral suspension

What is being measured

The primary outcome is the main question the study is designed to answer.

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.
Measured: From day1 up to day15

Secondary outcomes (8)

Time to Alleviation of Influenza Signs and Symptoms
Time to alleviation of influenza signs and symptoms is defined as the length of time taken from the start of treatment to the point at which all of the following criteria are met (Standard a or b) and remain so for at least 21.5 hours:
1. Body temperature returns to normal (axillary temperature ≤ 37.2℃)
2. In the CARIFS scale, a score of 0 (no problem) or 1 (minor problem) for cough ,rhinobyon or nasal symptoms.
Measured: From day1 up to day15
Duration of fever
Length of time taken by participants to return to afebrile state [axillary temperature ≤ 37.2°C] and remaining so for at least 21.5 hours.
Measured: From day1 up to day15
Time to Alleviation of Symptoms
Symptom recovery time: Defined as the period from the start of the study treatment until all 16 assessment items in the CARIFS were evaluated as being asymptomatic or mild, and remained so for at least 21.5 hours.
Measured: From day1 up to day15
Time to Return to Normal Health and Activity
Time to Return to Normal Health and Activity
Measured: From day1 up to day15
The time influenza RNA turns negative
Defined as the time from initiation of treatment until the first influenza viral RNA falls below the lower limit of quantification (measured by RT-PCR)
Measured: From day1 up to day15
The time Virus Titer turns negative
Defined as the time from initiation of treatment until the first viral titer falls below the lower limit of quantification
Measured: From day1 up to day15
Change From Baseline in the Amount of Virus RNA (RT-PCR) and Influenza Virus Titer at each visit
Change From Baseline in the Amount of Virus RNA (RT-PCR, unit: log10virus particles/mL) and Influenza Virus Titer (unit: log10TCID50/ML) at each visit
Measured: Baseline, Day 2,3,5,9,15
Percentage of Participants With Positive Influenza Virus Titer at each visit (measured by RT-PCR)
Percentage of Participants With Positive Influenza Virus Titer at each visit (measured by RT-PCR)(unit: %)
Measured: Baseline, Day 2,3,5,9,15

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

13 Oct 202516 Jan 2026

First posted31 Jul 2025
Study start13 Oct 2025
Primary completion16 Jan 2026
Study completion16 Jan 2026

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Other trials for Respiratory Viral InfectionStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 3
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Quadruple blind
Who is masked: Participant, Care provider, Investigator, Outcomes assessor
Enrolment: 169 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT07095257
Sponsor's protocol ID: ZX-7101A-214
Acronym: ZX-7101A-214
Status last verified: Apr 2026
First submitted: 24 Jul 2025
Last updated: 16 Apr 2026
Results posted: No
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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Study at a glance

From the registry record, last updated by the sponsor on 16 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Multicenter, Randomized, Double-blind, Positive Controlled, Phase III Trial to Evaluate the Safety and Efficacy of ZX-7101A for Oral Suspension in Pediatric Participants Aged 2 to 11 With Influenza
ClinicalTrials.gov ID: NCT07095257
Acronym / sponsor ID: ZX-7101A-214 / ZX-7101A-214
Conditions: Respiratory Viral Infection
Phase: Phase 3
Study type: Interventional
Recruitment status: Completed
Enrolment: 169 participants (actual)
Lead sponsor: Nanjing Zenshine PharmaceuticalsIndustry (pharma, biotech, devices)
Study start: 13 Oct 2025 (actual)
Primary completion: 16 Jan 2026 (actual)
Study completion: 16 Jan 2026 (actual)
First posted: 31 Jul 2025 (actual)
Results: Not posted in the source record

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

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.

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Quadruple blind (participant, care provider, investigator, outcomes assessor)
Number of arms: 2

Arm	Type	Receives
ZX-7101A for oral suspension	Experimental	Drug: ZX-7101A for oral suspensionA 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.
Oseltamivir phosphate for oral suspension	Active comparator	Drug: Oseltamivir phosphate for oral suspensionA 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.

Who may qualify

Ages: 2 to 11 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Child

Key inclusion criteria (9 listed)

≥2 to<12 years of age at the time of randomization, males or females.
Patients in the screening period met the following criteria:
The first occurrence of influenza symptoms ≤ 48 hours from the time of patient randomization. The occurrence of symptoms is defined as:
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).

Key exclusion criteria (22 listed)

Patients with severe or critically influenza virus infection (Meet any one of the following criteria).
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;
High risk population for severe cases (meeting any of the following criteria):
Individuals who have experienced acute respiratory infections or otitis media and sinusitis within the past 2 weeks prior to screening.

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
ZX-7101A for oral suspensionZX-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.	Drug	ZX-7101A for oral suspension
Oseltamivir phosphate for oral suspensionOseltamivir 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.	Drug	Oseltamivir phosphate for oral suspension

Primary outcome

Number of Participants with Treatment-Related Adverse Events as Assessed by CTCAE v5.0
Time frame: From day1 up to day15
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.

8 secondary outcomes

Time to Alleviation of Influenza Signs and Symptoms
Time frame: From day1 up to day15
Duration of fever
Time frame: From day1 up to day15
Time to Alleviation of Symptoms
Time frame: From day1 up to day15
Time to Return to Normal Health and Activity
Time frame: From day1 up to day15
The time influenza RNA turns negative
Time frame: From day1 up to day15
The time Virus Titer turns negative
Time frame: From day1 up to day15
Change From Baseline in the Amount of Virus RNA (RT-PCR) and Influenza Virus Titer at each visit
Time frame: Baseline, Day 2,3,5,9,15
Percentage of Participants With Positive Influenza Virus Titer at each visit (measured by RT-PCR)
Time frame: Baseline, Day 2,3,5,9,15

Results and safety

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 16 Apr 2026.
Individual participant dataSharing planned: No

Related trials for Respiratory Viral Infection

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VIRal Pulmonary Infections in Older AGE
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Active, not recruitingPhase 1
A Safety and Immunogenicity Trial of OCU500, ChAd36 Vector Encoding SARS-CoV-2 Spike Vaccine Via Intranasal and Inhalational Routes in Previously Vaccinated Adults
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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

The record lists no contact. Use the official record to reach the sponsor.

2 sites in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 9 inclusion and 22 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 16 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites in China. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Number of Participants with Treatment-Related Adverse Events as Assessed by CTCAE v5.0 (time frame: From day1 up to day15). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07095257.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Apr 2026.