Influenza, HumanPhase 2/3NCT05702489
A Study to Evaluate the Efficacy and Safety of ZX-7101A Tablets in Adults with Uncomplicated Influenza
A Phase 2/3 study testing ZX-7101A in people with Influenza, Human, run by Nanjing Zenshine Pharmaceuticals at 1 site in China.
Trial summary
The goal of this clinical trial is to compare ZX-7101A in Chinese Adults patients with uncomplicated influenza. The main questions it aims to answer are: The efficacy of ZX-7101A in Chinese Adults patients with uncomplicated influenza. The safety of ZX-7101A in Chinese Adults patients with uncomplicated influenza. Read more about this study
- Who is it for?
- Ages 18 to 64 years
- Conditions the study is for
- Influenza, Human
- What is being tested?
- ZX-7101A
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 900 participants
- Where
- 1 siteChina
- Study dates
- 17 Jul 2022to 13 Oct 2023
- Phase
- Phase 2/3
- 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 18 to 64 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- ≥18 to ≤64 years of age at the time of signing the ICF.
- Patients in the screening period met the following criteria: (1) rapid influenza diagnostic test (RIDT) or polymerase chain reaction (PCR) test positive; (2) fever ≥ 37.3℃ (axillary temperature) at screening; if taking antipyretics, axillary temperature ≥ 37.3℃ after taking the drug (more than 4 hours). (3) At least one of flu-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.
- The first occurrence of influenza symptoms ≤ 48 hours from the time of patient randomization.
Who cannot join
- Patients with influenza virus infection requiring hospitalization.
- High-risk population.
- Bronchitis, pneumonia, pleural effusion or interstitial disease suspected by a clinician or confirmed by chest imaging [X-ray (anteroposterior or anteroposterior)/CT] and judged clinically significant by the investigator at screening.
- Patients who have developed acute respiratory tract infection, otitis media, and sinusitis within 2 weeks before screening.
- Patients with other infections requiring systemic anti-infective treatment, or blood routine examination at screening: white blood cell count (WBC) > 10.0 × 109/L.
- Patients with purulent sputum or suppurative tonsillitis.
- Those who have difficulty in swallowing drugs or have a history of gastrointestinal diseases that seriously affect drug absorption.
- Medications against influenza virus within 7 days prior to Screening.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Multicenter, Randomized, Double-Blind, Placebo-Controlled, Phase 2/3 Study to Evaluate the Efficacy and Safety of ZX-7101A Tablets in Adults with Uncomplicated Influenza
The goal of this clinical trial is to compare ZX-7101A in Chinese Adults patients with uncomplicated influenza. The main questions it aims to answer are:
- The efficacy of ZX-7101A in Chinese Adults patients with uncomplicated influenza.
- The safety of ZX-7101A in Chinese Adults patients with uncomplicated influenza.
- Conditions
- Influenza, Human
- Being tested
- ZX-7101A
- 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
a drug to treatment influenza in Chinese adults
| Study group | Role | What they receive |
|---|---|---|
| ZX-7101A low dose group | Experimental | 40 mg, tablet, single oral administration when the subject screened successfully Receives: Drug: ZX-7101A |
| ZX-7101A high dose group | Experimental | 80 mg, tablet, single oral adminitration when the subject screened successfully Receives: Drug: ZX-7101A |
| Placebo control | Placebo comparator | Analog tablet with no active ingredient, single oral administration when the subject screened successfully Receives: Drug: ZX-7101A |
What is being measured
The primary outcome is the main question the study is designed to answer.
The time to the remission of all influenza symptoms (hours)
Defined as the time from the start of study treatment to the time all flu symptoms are relieved. Symptom relief was defined as all seven influenza symptoms assessed by the subject on the subject diary card(Stuffy nose, sore throat, cough, muscle or joint pain, fatigue, headache, fever or chills/sweating) were 0 (asymptomatic) or 1 (mild);
Measured: from accepting ZX-7101A until the 15 days after the first dosing
Secondary outcomes (1)
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 (P Wave, QRS Complex, QT Interval), physical examination, and Laboratory test compared with the baseline.
Measured: from accepting ZX-7101A until the 15 days after the first dosing
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jan 2023
- Study start17 Jul 2022
- Primary completion26 May 2023
- Study completion13 Oct 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Influenza, HumanStudies 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 2/3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 900 participants (actual)
Sponsor and investigators
- Lead sponsor
- Nanjing Zenshine Pharmaceuticals
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- hong wen Zhang, doctor, Principal investigator, Huashan Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05702489
- Sponsor's protocol ID
- ZX-7101A-202
- Status last verified
- Nov 2024
- First submitted
- 16 Jan 2023
- Last updated
- 5 Nov 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Nov 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multicenter, Randomized, Double-Blind, Placebo-Controlled, Phase 2/3 Study to Evaluate the Efficacy and Safety of ZX-7101A Tablets in Adults with Uncomplicated Influenza
- ClinicalTrials.gov ID
- NCT05702489
- Acronym / sponsor ID
- ZX-7101A-202
- Conditions
- Influenza, Human
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 900 participants (actual)
- Lead sponsor
- Nanjing Zenshine PharmaceuticalsIndustry (pharma, biotech, devices)
- Study start
- 17 Jul 2022 (actual)
- Primary completion
- 26 May 2023 (actual)
- Study completion
- 13 Oct 2023 (actual)
- First posted
- 27 Jan 2023 (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 clinical trial is to compare ZX-7101A in Chinese Adults patients with uncomplicated influenza. The main questions it aims to answer are:
- The efficacy of ZX-7101A in Chinese Adults patients with uncomplicated influenza.
- The safety of ZX-7101A in Chinese Adults patients with uncomplicated influenza.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| ZX-7101A low dose group | Experimental | Drug: ZX-7101A40 mg, tablet, single oral administration when the subject screened successfully |
| ZX-7101A high dose group | Experimental | Drug: ZX-7101A80 mg, tablet, single oral adminitration when the subject screened successfully |
| Placebo control | Placebo comparator | Drug: ZX-7101AAnalog tablet with no active ingredient, single oral administration when the subject screened successfully |
Who may qualify
- Ages
- 18 to 64 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- ≥18 to ≤64 years of age at the time of signing the ICF.
- Patients in the screening period met the following criteria: (1) rapid influenza diagnostic test (RIDT) or polymerase chain reaction (PCR) test positive; (2) fever ≥ 37.3℃ (axillary temperature) at screening; if taking antipyretics, axillary temperature ≥ 37.3℃ after taking the drug (more than 4 hours). (3) At least one of flu-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.
- The first occurrence of influenza symptoms ≤ 48 hours from the time of patient randomization.
Key exclusion criteria (8 listed)
- Patients with influenza virus infection requiring hospitalization.
- High-risk population.
- Bronchitis, pneumonia, pleural effusion or interstitial disease suspected by a clinician or confirmed by chest imaging [X-ray (anteroposterior or anteroposterior)/CT] and judged clinically significant by the investigator at screening.
- Patients who have developed acute respiratory tract infection, otitis media, and sinusitis within 2 weeks before screening.
- Patients with other infections requiring systemic anti-infective treatment, or blood routine examination at screening: white blood cell count (WBC) > 10.0 × 109/L.
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-7101Aa drug to treatment influenza in Chinese adults | Drug | Placebo control, ZX-7101A high dose group, ZX-7101A low dose group |
Primary outcome
The time to the remission of all influenza symptoms (hours)
Time frame: from accepting ZX-7101A until the 15 days after the first dosing
Defined as the time from the start of study treatment to the time all flu symptoms are relieved. Symptom relief was defined as all seven influenza symptoms assessed by the subject on the subject diary card(Stuffy nose, sore throat, cough, muscle or joint pain, fatigue, headache, fever or chills/sweating) were 0 (asymptomatic) or 1 (mild);
1 secondary outcome
Number of Participants with Treatment-Related Adverse Events as Assessed by CTCAE v5.0
Time frame: from accepting ZX-7101A until the 15 days after the first dosing
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 5 Nov 2024.
- Individual participant dataSharing planned: No
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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.
hong wen Zhang, doctor principal investigator
Huashan Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2/3 study testing ZX-7101A in people with Influenza, Human, run by Nanjing Zenshine Pharmaceuticals 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 3 inclusion and 8 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 5 Nov 2024. 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 combined 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.
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?
The time to the remission of all influenza symptoms (hours) (time frame: from accepting ZX-7101A until the 15 days after the first dosing). 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 5 Nov 2024.