Influenza APhase 3NCT07229820
Efficacy and Safety of ZSP1273 in Children 12-17 Years Old With Influenza A
A Phase 3 study testing ZSP1273 in people with Influenza A, run by Guangdong Raynovent Biotech Co., Ltd at 1 site in China.
Trial summary
This trial is conducted in China. This is a multi-center, randomized, double-blind, placebo-controlled clinical trial to assess the efficacy and safety of ZSP1273 in the treatment of Acute Uncomplicated influenza A in adolescents. Read more about this study
- Who is it for?
- Ages 12 to 17 years
- Conditions the study is for
- Influenza A
- What is being tested?
- ZSP1273
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 157 participants
- Where
- 1 siteChina
- Study dates
- 8 Nov 2025to 31 Dec 2025
- Phase
- Phase 3
- Are there results?
- Not yet: the study is under way
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 12 to 17 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Participants 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 participants aged ≥ 2 to ≤11 years at the time of signing the informed consent form.
- Participants 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 48 hours or less;
- Fever ≥ 38ºC (axillary temperature); and at least one following respiratory symptoms associated with influenza virus infection is present
Who cannot join
- Participants with severe influenza virus infection；
- Participants 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；
- Participants with concurrent infections requiring antimicrobial therapy；
- Participants who are considered inappropriate for the study by the investigator.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Randomized, Double-blind Phase III Clinical Study of ZSP1273 Tablets Compared With Placebo in Children 12-17 Years Old With Acute Uncomplicated Influenza A
This trial is conducted in China. This is a multi-center, randomized, double-blind, placebo-controlled clinical trial to assess the efficacy and safety of ZSP1273 in the treatment of Acute Uncomplicated influenza A in adolescents.
- Conditions
- Influenza A
- Being tested
- ZSP1273, Placebo
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ZSP1273Drug
Oral
PlaceboDrug
Oral
| Study group | Role | What they receive |
|---|---|---|
| ZSP1273 | Experimental | Not described Receives: Drug: ZSP1273 |
| Placebo | Placebo comparator | Not described Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Time to Alleviation of Symptoms
Participants assessed the severity of seven influenza-associated symptoms (cough, sore throat, headache, nasal congestion, feverishness or chills, muscle or joint pain, and fatigue) on a 4-point scale (with 0 indicating no symptoms, 1 mild symptoms, 2 moderate symptoms, and 3 severe symptoms).
Measured: DAY1~DAY15
Secondary outcomes (2)
Number of participants with treatment-related adverse events as assessed by CTCAE v5.0
Measured: DAY1~DAY15
Plasma concentrations of ZSP1273
Measured: DAY1~DAY15
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Nov 2025
- Study start8 Nov 2025
- Primary completion22 Dec 2025 (estimated)
- Study completion31 Dec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Influenza AStudies 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
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 157 participants (actual)
Sponsor and investigators
- Lead sponsor
- Guangdong Raynovent Biotech Co., Ltd
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07229820
- Sponsor's protocol ID
- ZSP1273-25-21
- Status last verified
- Oct 2025
- First submitted
- 13 Nov 2025
- Last updated
- 16 Dec 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Double-blind Phase III Clinical Study of ZSP1273 Tablets Compared With Placebo in Children 12-17 Years Old With Acute Uncomplicated Influenza A
- ClinicalTrials.gov ID
- NCT07229820
- Acronym / sponsor ID
- ZSP1273-25-21
- Conditions
- Influenza A
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 157 participants (actual)
- Lead sponsor
- Guangdong Raynovent Biotech Co., LtdIndustry (pharma, biotech, devices)
- Study start
- 8 Nov 2025 (actual)
- Primary completion
- 22 Dec 2025 (estimated)
- Study completion
- 31 Dec 2025 (estimated)
- First posted
- 17 Nov 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.
This trial is conducted in China. This is a multi-center, randomized, double-blind, placebo-controlled clinical trial to assess the efficacy and safety of ZSP1273 in the treatment of Acute Uncomplicated influenza A in adolescents.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| ZSP1273 | Experimental | Drug: ZSP1273 |
| Placebo | Placebo comparator | Drug: Placebo |
Who may qualify
- Ages
- 12 to 17 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (6 listed)
- Participants 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 participants aged ≥ 2 to ≤11 years at the time of signing the informed consent form.
- Participants with a diagnosis of influenza virus infection confirmed by all of the following:
Key exclusion criteria (7 listed)
- Participants with severe influenza virus infection；
- Participants 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；
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 |
|---|---|---|
| ZSP1273Oral | Drug | ZSP1273 |
| PlaceboOral | Drug | Placebo |
Primary outcome
Time to Alleviation of Symptoms
Time frame: DAY1~DAY15
Participants assessed the severity of seven influenza-associated symptoms (cough, sore throat, headache, nasal congestion, feverishness or chills, muscle or joint pain, and fatigue) on a 4-point scale (with 0 indicating no symptoms, 1 mild symptoms, 2 moderate symptoms, and 3 severe symptoms).
2 secondary outcomes
Number of participants with treatment-related adverse events as assessed by CTCAE v5.0
Time frame: DAY1~DAY15
Plasma concentrations of ZSP1273
Time frame: DAY1~DAY15
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Dec 2025.
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Healthy Participants
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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing ZSP1273 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: under way, not looking for participants, as of the sponsor's last update on 16 Dec 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. Some participants in this study may receive a placebo. 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?
This study is still under way. Results are not available in the source record yet.
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?
Time to Alleviation of Symptoms (time frame: DAY1~DAY15). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 Dec 2025.