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TerminatedNCT06669351ZX-7101A-210Updated Aug 13, 2025

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

A Phase 3 interventional study of ZX-7101A and Placebo for ZX-7101A tablet in Respiratory Viral Infection, sponsored by Nanjing Zenshine Pharmaceuticals. Terminated at 3 sites in China. Open to participants aged 5 Years to 11 Years. Per ClinicalTrials.gov, last updated 2025-08-13.

Sponsored by Nanjing Zenshine Pharmaceuticals · Phase 3, Interventional, and Treatment

Why this study was terminated
Due to the company's development strategy.
Phase
Phase 3
Study type
Interventional
Enrollment
98
Allocation
Randomized
Ages
5 Years to 11 Years
Sex
All
01

Study 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 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).

02

Conditions studied

  • Respiratory Viral Infection

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Keywords

  • influenza
03

In context

Influenza, Human

2,214 studies on the registry are indexed under Influenza, Human; 163 are open to participants now.

This study's enrollment of 98 is below the median of 238 across 1,853 interventional studies indexed under Influenza, Human.

Browse Influenza, Human studies →

Lead sponsor

Nanjing Zenshine Pharmaceuticals is the lead sponsor of 16 studies on the registry; 2 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
5 Years to 11 Years
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  • 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:

    1. Rapid influenza diagnostic test (RIDT) or polymerase chain reaction (PCR) test positive;
    2. Axillary temperature ≥ 37.5℃ at screening; If taking antipyretics, axillary temperature ≥ 37.5℃ after taking the drug (more than 4 hours).
    3. 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.
    4. At least one of the influenza-related respiratory symptoms is moderate or greater in severity: a. nasal congestion, b. sore throat, c. cough.

  • 3. The first occurrence of influenza symptoms ≤ 48 hours from the time of patient randomization.

    1. Body temperature ≥ 37.5 ℃ (axillary temperature) or 37.5 ℃ (oral temperature) or 38.0 ℃ (rectal or tympanic membrane temperature)for the first time;
    2. 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).

Exclusion criteria

Exclusion Criteria:

  • Patients with severe influenza virus infection requiring inpatient treatment. (Meet any one of the following criteria)

    1. 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;
      • Concomitant pneumonia;
      • Significant exacerbation of existing underlying diseases;
      • Other clinical situations that require hospitalization.

    2. 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):

    1. 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;
    2. 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;
    3. Clinical significance of correcting QT interval abnormalities in electrocardiogram display; (QTc>440ms in male or QTc>450ms in female);
    4. 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;
    5. 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.
05

Study design

Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Quadruple (Participant, Care provider, Investigator, Outcomes assessor)
Enrollment
98 participants (actual)

Study arms

  • Experimental
    Single Arm

    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.

    Drug: ZX-7101A

  • Active comparator
    Oseltamivir phosphate dry suspension:

    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 (2 tablets，specification：10mg, single dose) or oseltamivir phosphate dry suspension（specification：0.36g）.

    Other: Placebo for ZX-7101A tablet · Drug: Oseltamivir phosphate dry suspension

  • Experimental
    ZX-7101A

    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 (2 tablets，specification：10mg, single dose) or oseltamivir phosphate dry suspension（specification：0.36g）.

    Drug: ZX-7101A · Other: Placebo for Oseltamivir phosphate dry suspension:

Interventions

  • DrugZX-7101A

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

  • OtherPlacebo for ZX-7101A tablet

    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.

  • DrugOseltamivir phosphate dry suspension

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

  • OtherPlacebo for Oseltamivir phosphate dry suspension:

    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.

06

What researchers measure

Primary outcomes

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

    Part 1: Time to peak drug concentration (Tmax)

    Time frame: 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)

    Time frame: 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)

    Time frame: 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)

    Time frame: 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.

    Time frame: Part 2: From day1 up to day15

Secondary outcomes

  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.

    Time frame: 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%)

    Time frame: 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: %);

    Time frame: 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).

    Time frame: 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)

    Time frame: 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.

    Time frame: 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 (%)

    Time frame: Part 2: Baseline, Day1, Day2, Day3, Day5, Day9, Day15

07

Study locations

3 sites
  • Baoding Hospital of Beijing Children's Hospital, Capital Medical University
    Baoding, Hebei, China
  • West China Second University Hospital, Sichuan University
    Chengdu, Sichuan, China
  • Children's Hospital Zhejiang University School of Medicine
    Hangzhou, Zhejiang, China
08

References and documents

Individual participant data

Plan to share: No — The results of the trial will be used for New Drug Application.

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Aug 13, 2025, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT06669351
Lead sponsor
Nanjing Zenshine Pharmaceuticals
Responsible party
Sponsor
First posted
Nov 1, 2024
Start date
Oct 31, 2024
Primary completion
Jul 15, 2025
Completion
Jul 15, 2025
Last update
Aug 13, 2025

Study contacts

Hanmin Liu, MD
principal investigator · The Children's Hospital of Zhejiang University School of Medicine

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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