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Respiratory Viral InfectionPhase 3ZX-7101A-210NCT06669351

Study to Assess the Safety and Efficacy of ZX-7101A in Children Aged 5-11 Years With Influenza

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

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record
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Trial summary

A multicenter, randomized, double-blind, positive controlled, phase III trial to evaluate the safety and efficacy of ZX-7101A tablets versus oseltamivir phosphate suspension in children aged ≥5 years and < 12 years with uncomplicated influenza. Read more about this study

Who is it for?
Ages 5 to 11 years
Conditions the study is for
Respiratory Viral Infection
What is being tested?
ZX-7101A and Oseltamivir phosphate dry suspension
Type of treatment
Pill or oral medicine
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
98 participants
Where
3 sitesChina
Study dates
31 Oct 2024to 15 Jul 2025
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 5 to 11 years
  • All sexes
  • No healthy volunteers
  • Child

Who may be able to join

  • 1.≥5 to<12 years of age at the time of randomization, males or females.
  • 2.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 influenza -related systemic symptoms is moderate or greater in severity: a. muscle or joint pain, b. fatigue, c. headache, d. fever.
  • At least one of the influenza-related respiratory symptoms is moderate or greater in severity: a. nasal congestion, b. sore throat, c. cough.
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  • 3. The first occurrence of influenza symptoms ≤ 48 hours from the time of patient randomization.
  • Body temperature ≥ 37.5 ℃ (axillary temperature) or 37.5 ℃ (oral temperature) or 38.0 ℃ (rectal or tympanic membrane temperature)for the first time;
  • Or at least one systemic or respiratory symptom may occur: a. nasal congestion, b. sore throat, c. cough, d. muscle or joint pain, e. fatigue, f. headache, g. fever.
  • 4. Both the subject and his/her guardian are volunteer to participate in the study and sign the written informed consent form (ICF), the subject could comply with all the study procedures, complete the subject diary as required (the guardian is allowed to fill in if necessary).

Who cannot join

  • Patients with severe influenza virus infection requiring inpatient treatment. (Meet any one of the following criteria)
  • Severe cases with one of the following conditions：
  • Persistent high fever for more than 3 days, accompanied by severe cough, purulent sputum, bloody sputum, or chest pain;
  • Fast breathing rate, difficulty breathing, cyanosis of lips;
  • Delayed response, drowsiness, restlessness, and other mental changes or seizures;
  • Severe vomiting, diarrhea, and dehydration symptoms;
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  • Concomitant pneumonia;
  • Significant exacerbation of existing underlying diseases;
  • Other clinical situations that require hospitalization.
  • Critical cases with one of the following conditions (Including but not limited to)：
  • Respiratory failure;
  • Acute necrotizing encephalopathy;
  • Shock;
  • Multiple organ dysfunction;
  • Other serious clinical situations that require monitoring and treatment.
  • 2. High risk population for severe cases. (Meet any one of the following criteria):
  • Accompanied by the following basic diseases and judged by the investigators to be clinically significant, such as lung diseases, liver diseases, kidney diseases, hematological system diseases, heart diseases, neurological and neuromuscular diseases that affect the ability to clear respiratory secretions, metabolic and endocrine system diseases, etc;
  • Subjects with low immune function, such as malignant tumors, organ or bone marrow transplants, HIV infections, or those who have been taking immunosuppressants for the past 3 months;
  • Clinical significance of correcting QT interval abnormalities in electrocardiogram display; (QTc>440ms in male or QTc>450ms in female);
  • Subjects who require long-term use of drugs containing aspirin or salicylates : It is necessary to take medication containing aspirin or salicylate regularly every day for more than 14 days;
  • BMI exceeds the standards.
  • 3. Bronchitis, pneumonia, pleural effusion or interstitial disease confirmed by chest imaging [X-ray (anteroposterior or anteroposterior) /CT] and judged clinically significant by the investigator at screening.
  • 4. Subjects who have developed acute respiratory tract infection, otitis media, and sinusitis within 2 weeks before screening.
  • 5. Subjects with other respiratory infections requiring systemic anti-infective treatment, or blood routine examination at screening: white blood cell count (WBC) > (venous blood)
  • 6. Subjects with purulent sputum or suppurative tonsillitis.
  • 7. Have difficulty in swallowing drugs or have a history of gastrointestinal diseases that seriously affect drug absorption (including but not limited to reflux esophagitis, chronic diarrhea, inflammatory bowel disease, intestinal tuberculosis, gastrinoma, short bowel syndrome, subtotal gastrectomy, etc.).
  • 8. Suspected allergic to active ingredients or excipients of the investigational product.
  • 9. Body weight < 20 kg.
  • 10. Medications against influenza virus within 7 days before screening (including but not limited to: neuraminidase inhibitors, hemagglutinin inhibitors, M2 ion channel blockers, and cap structure inhibitors. Lysine endonuclease (CEN) inhibitors, such as oseltamivir, zanamivir, peramivir, favipiravir, rimantadine, amantadine, abidol, baloxavir, etc.).
  • 11. Have received live vaccines or attenuated live vaccines within 14 days before randomization, influenza vaccines within 6 months before randomization.
  • 12. Suspected or confirmed a history of alcohol or drug abuse.
  • 13. Ppregnancy test was positive
  • 14. Participants who participated in another clinical trial and used any other investigational drug or device within 30 days before screening.
  • 15. Subjects judged by the investigator to be ineligible for participation in the study.

Trial locations and contacts

3 sites in 1 country.

China3 sites

  • Baoding Hospital of Beijing Children's Hospital, Capital Medical University

    Baoding, Hebei

  • 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 Clinical Trial of ZX-7101A Tablets to Evaluate the Safety and Efficacy in the Treatment of Uncomplicated Influenza in Children Aged 5-11 Years

A multicenter, randomized, double-blind, positive controlled, phase III trial to evaluate the safety and efficacy of ZX-7101A tablets versus oseltamivir phosphate suspension in children aged ≥5 years and < 12 years with uncomplicated influenza.

Read the detailed description

Part 1:

A pilot study of pharmacokinetics, safety, and efficacy was conducted in children (5-11 years old, weight ≥20kg) with uncomplicated influenza. A total of 12 subjects were planned to be enrolled. (Pharmacokinetic and safety data from at least 8 children are required.) On the first day, ZX-7101A 20 mg tablets, 2 tablets (specification: 10 mg/ tablet) were taken orally. PK samples were collected before and after the first (D1) dose: 1 to 2 h, 4 h, 8 h, 24 h (D2), 96 h (D5), 192 h (D9) and 336 h (D15) after administration.

Part 2:

A randomized phase III study with safety as primary endpoint was conducted in children (5-11 years old, body weight ≥20kg) with uncomplicated influenza. Eligible subjects were randomly assigned in a 2:1 ratio to receive either ZX-7101A or oseltamivir phosphate.

Enrolled subjects were required to have typical systemic and/or respiratory influenza symptoms, with first influenza symptoms occurring within 48 hours of randomization. The study was divided into a screening/treatment period (D1) and an observation period (approximately 2 weeks).

Being tested
ZX-7101A, Placebo for ZX-7101A tablet, Oseltamivir phosphate dry suspension, Placebo for Oseltamivir phosphate dry suspension:
Keywords
influenza
Medical subject headings
Influenza, Human

What participants receive

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

  • ZX-7101ADrug

    On day1: Take two tablets of ZX-7101A orally once (specification: 10mg/ tablet) with appropriate amount of warm water

  • Placebo for ZX-7101A tabletOther

    Placebo for ZX-7101A tablet:

    The appearance and properties of placebo tablets were identical to those of the trial drug ZX-7101A tablets. On Day 1, two placebo for ZX-7101A tablets were taken orally with appropriate warm water.

  • Oseltamivir phosphate dry suspensionDrug

    Drug: Oseltamivir phosphate dry suspension:

    From Day1 to Day 5 : Oseltamivir phosphate suspension was orally administered twice a day, dose according to the label.

  • Placebo for Oseltamivir phosphate dry suspension:Other

    Drug: Placebo for Oseltamivir phosphate dry suspension:

    From Day1 to Day 5 : Placebo for Oseltamivir phosphate suspension was orally administered twice a day, dose according to the label.

Study groups in NCT06669351
Study groupRoleWhat they receive
Single ArmExperimentalPart 1: A pilot study of pharmacokinetics, safety, and efficacy was conducted in children (5-11 years old, weight ≥20kg) with uncomplicated influenza. A total of 12 subjects were planned to be enrolled.
Receives: Drug: ZX-7101A
Oseltamivir phosphate dry suspension:Active comparatorPart 2: A randomized phase III study with safety as primary endpoint was conducted in children (5-11 years old, body weight ≥20kg) with uncomplicated influenza. Eligible subjects were randomly assigned in a 2:1 ratio to receive either ZX-7101A (2 tablets，specification：10mg, single dose) or oseltamivir phosphate dry suspension（specification：0.36g）.
Receives: Other: Placebo for ZX-7101A tablet; Drug: Oseltamivir phosphate dry suspension
ZX-7101AExperimentalPart 2: A randomized phase III study with safety as primary endpoint was conducted in children (5-11 years old, body weight ≥20kg) with uncomplicated influenza. Eligible subjects were randomly assigned in a 2:1 ratio to receive either ZX-7101A (2 tablets，specification：10mg, single dose) or oseltamivir phosphate dry suspension（specification：0.36g）.
Receives: Drug: ZX-7101A; Other: Placebo for Oseltamivir phosphate dry suspension:

What is being measured

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

  1. Pharmacokinetic parameters of ZX-7101A and its metabolite ZX-7101 in plasma

    Part 1:

    Time to peak drug concentration (Tmax)

    Measured: Part 1: 1~2, 4, 8, 24, 96 ,192, 336 hours post-dose

  2. Pharmacokinetic parameters of ZX-7101A and its metabolite ZX-7101 in plasma

    Part 1:

    Peak plasma concentration (Cmax)

    Measured: Part 1: 1~2, 4, 8, 24, 96 ,192, 336 hours post-dose

  3. Pharmacokinetic parameters of ZX-7101A and its metabolite ZX-7101 in plasma

    Part 1:

    Area under the plasma concentration versus time curve (AUC)

    Measured: Part 1: 1~2, 4, 8, 24, 96 ,192, 336 hours post-dose

  4. Pharmacokinetic parameters of ZX-7101A and its metabolite ZX-7101 in plasma

    Part 1:

    The terminal elimination half-life (t1/2)

    Measured: Part 1: 1~2, 4, 8, 24, 96 ,192, 336 hours post-dose

  5. Number of Participants with Treatment-Related Adverse Events as Assessed by CTCAE v5.0

    Part 2:

    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: Part 2: From day1 up to day15

Secondary outcomes (7)

  1. Number of Participants with Treatment-Related Adverse Events as Assessed by CTCAE v5.0

    Part 1:

    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: Part 1: From day1 up to day15

  2. Time (in hours) for relief of 7 all influenza symptoms

    Part 2:

    Symptom remission is defined as a score of 0 (asymptomatic) or 1 (mild) for all seven influenza symptoms assessed by the subject on the subject diary card. And lasts for at least 21.5 hours (approximately 24 hours-10%)

    Measured: Part 2: Baseline, Day 1 up to Day 15

  3. Proportion of all subjects with remission of influenza symptoms

    Part 2: Proportion of subjects with remission of all influenza symptoms at each visit and each evaluation time point (unit: %);

    Measured: Part 2: Baseline, Day 1 up to Day 15

  4. Influenza virus RNA clearance time (in hours)

    Part 2: The time to influenza RNA clearance in hours was defined as the time from the start of study treatment to the first time influenza RNA was below the lower limit of quantification (as measured by RT-PCR).

    Measured: Part 2: Baseline, Day1, Day2, Day3, Day5, Day9, Day15

  5. Time for influenza virus titer to become negative

    Part 2: Time for influenza virus titer to become negative (in hours)

    Measured: Part 2: Baseline, Day1, Day2, Day3, Day5, Day9, Day15

  6. Changes in influenza RNA and virus titers

    Changes from baseline in RT-PCR-determined influenza RNA (log10 viral copies per milliliter) and virus titers (log10TCID50 per milliliter) at each visit.

    Measured: Part 2: Baseline, Day1, Day2, Day3, Day5, Day9, Day15

  7. Influenza virus RNA

    Proportion of subjects positive for influenza virus RNA by RT-PCR and with detectable virus titers at each visit (%)

    Measured: Part 2: Baseline, Day1, Day2, Day3, Day5, Day9, Day15

Timeline

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

  1. First posted1 Nov 2024
  2. Study start31 Oct 2024
  3. Primary completion15 Jul 2025
  4. Study completion15 Jul 2025

Why it stopped: Due to the company's development strategy.

Resources

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
Model description
Part 1: A pilot study of pharmacokinetics, safety, and efficacy was conducted in children (5-11 years old, weight ≥20kg) with uncomplicated influenza. A total of 12 subjects were planned to be enrolled. (Pharmacokinetic and safety data from at least 8 children are required.) Part 2: A randomized phase III study with safety as primary endpoint was conducted in children (5-11 years old, body weight ≥20kg) with uncomplicated influenza. Eligible subjects were randomly assigned in a 2:1 ratio to receive either ZX-7101A or oseltamivir phosphate. Enrolled subjects were required to have typical systemic and/or respiratory influenza symptoms, with first influenza symptoms occurring within 48 hours of randomization. A total of 168 subjects were planned to be enrolled.
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
98 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06669351
Sponsor's protocol ID
ZX-7101A-210
Acronym
ZX-7101A-210
Status last verified
Aug 2025
First submitted
30 Oct 2024
Last updated
13 Aug 2025
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No: The results of the trial will be used for New Drug Application.

Questions about this trial

What is this clinical trial studying?

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

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 10 inclusion and 34 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: stopped early, as of the sponsor's last update on 13 Aug 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 3 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 was stopped early (reason given: Due to the company's development strategy.). Results are not available in the source record.

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?

Pharmacokinetic parameters of ZX-7101A and its metabolite ZX-7101 in plasma (time frame: Part 1: 1~2, 4, 8, 24, 96 ,192, 336 hours post-dose). The study lists 5 primary outcomes in all. 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 NCT06669351.

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 13 Aug 2025.

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