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Influenza aPhase 2NCT06656026

Pharmacokinetics，Safety and Efficacy of ZSP1273 in Children 2-17 Years Old With Influenza A

A Phase 2 study testing ZSP1273 granules in people with Influenza a, run by Guangdong Raynovent Biotech Co., Ltd at 1 site 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

This trial is conducted in China. The aim of the trial is to investigate safety,pharmacokinetics and pharmacodynamics of ZSP1273 granules Read more about this study

Who is it for?
Ages 2 to 17 years
Conditions the study is for
Influenza a
What is being tested?
ZSP1273 granules
Type of treatment
Pill or oral medicine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
72 participants
Where
1 siteChina
Study dates
30 Nov 2024to 31 Jul 2025
Phase
Phase 2
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 17 years
  • All sexes
  • No healthy volunteers
  • Child

Who may be able to join

  • Subjects and their guardians who are able to understand the study and comply with all study procedures, and willing to provide written informed consent/assent prior to the predose examinations appropriately.
  • Male or female subjects aged ≥ 2 to ≤17 years at the time of signing the informed consent form.
  • Subjects with a diagnosis of influenza virus infection confirmed by all of the following:
  • Positive rapid antigen test (RAT) for influenza with nasal or throat swabs;
  • The time interval between the onset of symptoms and enrollment is 72 hours or less;
  • Fever ≥ 38ºC (axillary temperature); and at least one following respiratory symptoms associated with influenza virus infection is present

Who cannot join

  • Subjects with severe influenza virus infection；
  • Subjects with any medical history in gastrointestinal that interferes with the absorption of drugs；
  • Immunodeficiency,including malignant tumor,organ or marrow transplant,human immunodeficiency virus [HIV] infection,or patients receiving immunosuppressant therapy 3 months prior to enrollment；
  • Have received any other investigational products within 3 months prior to dosing；
  • Positive urine pregnancy test；
  • Subjects with concurrent infections requiring antimicrobial therapy；
  • Subjects who are considered inappropriate for the study by the investigator.

Trial locations and contacts

1 site in 1 country.

China1 site

  • The First Affiliated Hospital Of Guangzhou Medical University

    Guangzhou, Guangdong

Other trials in China

About this study

Official title: A Open-label Phase 2 Study of ZSP1273 in Otherwise Healthy Children 2-17 Years Old With Influenza A

This trial is conducted in China. The aim of the trial is to investigate safety,pharmacokinetics and pharmacodynamics of ZSP1273 granules

Conditions
Influenza a
Being tested
ZSP1273 granules

What participants receive

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

  • ZSP1273 granulesDrug

    Oral

Study groups in NCT06656026
Study groupRoleWhat they receive
ZSP1273(Arm a)Experimental* ≥2 ，<6 year old，dose 1 QD；5day * ≥6 ，<12 year old，dose 2 QD；5day * ≥12，≤17 year old，dose 3 QD；5day
Receives: Drug: ZSP1273 granules
ZSP1273(Arm b)Experimental* ≥2 ，<6 year old，dose 4 QD；5day * ≥6 ，<12 year old，dose 5 QD；5day * ≥12，≤17 year old，dose 6 QD；5day
Receives: Drug: ZSP1273 granules

What is being measured

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

  1. Plasma concentrations of ZSP1273

    Measured: DAY1~5

Secondary outcomes (3)

  1. Number of participants with treatment-related adverse events as assessed by CTCAE v5.0

    Measured: DAY1~29

  2. Time to alleviation of influenza symptoms (duration of influenza)

    Measured: DAY1~29

  3. Percentage of subjects with virus titer detected

    Measured: DAY1~29

Timeline

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

  1. First posted24 Oct 2024
  2. Study start30 Nov 2024
  3. Primary completion30 Jun 2025
  4. Study completion31 Jul 2025

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 2
Primary purpose
Basic science
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
72 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06656026
Sponsor's protocol ID
ZSP1273-23-17
Status last verified
Oct 2024
First submitted
14 Oct 2024
Last updated
17 Nov 2025
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No

Publications

  • Qin Q, Ma C, Yang Y, Li H, Xu S, Chi Y, Tang Z, Li S, Chen X, Zhao W, Xu B. Pharmacokinetics, Safety, and Exploratory Efficacy of Onradivir in Children with Acute Uncomplicated Influenza: A Multicenter, Dose-Ranging, Phase 2 Study. Infect Dis Ther. 2026 Sep 11. doi: 10.1007/s40121-026-01432-2. Online ahead of print.

    PubMed 42728468

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing ZSP1273 granules in people with Influenza a, run by Guangdong Raynovent Biotech Co., Ltd at 1 site 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 6 inclusion and 7 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 17 Nov 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

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?

Plasma concentrations of ZSP1273 (time frame: DAY1~5). 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 NCT06656026, which also lists 1 linked publication.

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 17 Nov 2025.

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