Respiratory Viral InfectionPhase 3ZX-7101A-207NCT06099873
Study to Assess the Safety and Efficacy of ZX-7101A in Adolescents With Influenza
A Phase 3 study testing ZX-7101A in people with Respiratory Viral Infection, run by Nanjing Zenshine Pharmaceuticals at 1 site in China.
Trial summary
The primary object of this study is evaluating the efficacy of ZX-7101A tablets versus placebo in the treatment of uncomplicated simple influenza in adolescents. The seongdary object is evaluating the safety of ZX-7101A tablet in the treatment of uncomplicated simple influenza in adolescents. Read more about this study
- Who is it for?
- Ages 12 to 17 years
- Conditions the study is for
- Respiratory Viral Infection
- 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
- 361 participants
- Where
- 1 siteChina
- Study dates
- 30 Nov 2023to 13 Feb 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 12 to 17 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- 1.≥12 to<18 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.
- 3.The first occurrence of influenza symptoms ≤ 48 hours from the time of patient randomization.
Show all 11Show fewer
- 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.Be able to comply with all the study procedures, complete the subject diary as required(The guardian is allowed to fill in if necessary).
- 5.The subject and his/her guardian are volunteer to participate in the study and sign the written informed consent form (ICF).
- 6.The subject agree to maintain abstinence or take reliable contraceptive methods during the trial and persist in until 3 months after the administration of the investigational product.
Who cannot join
- 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.
- 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 infections requiring systemic anti-infective treatment, or blood routine examination at screening: <13 years of age ：white blood cell count (WBC) > 11.3 × 109/L(venous blood);≥13 to<18 years of age ：white blood cell count (WBC) > 11.0 × 109/L(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.
Show all 9Show fewer
- 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. 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.
Trial locations and contacts
1 site in 1 country.
China1 site
Fudan University affiliated Huashan Hospital
Shanghai, Shanghai Municipality
About this study
Official title: A Multicenter, Randomized, Double-blind, Placebo-controlled Phase III Trial of ZX-7101A Tablets to Evaluate the Efficacy and Safety in the Treatment of Uncomplicated Influenza in Adolescents
The primary object of this study is evaluating the efficacy of ZX-7101A tablets versus placebo in the treatment of uncomplicated simple influenza in adolescents.
The seongdary object is evaluating the safety of ZX-7101A tablet in the treatment of uncomplicated simple influenza in adolescents.
Read the detailed description
In this study, adolescents aged 12 and < 18 with uncomplicated influenza are selected as subjects. Typical systemic and/or respiratory influenza symptoms were required, and the time interval between the first onset of influenza symptoms and random enrollment was less than 48 hours. This study is divided into screening/treatment period (D1) and observation period (about 2 weeks). You will be eligible before starting study therapy on day 1 (D1). Participants were randomly assigned 1:1 to ZX-7101A group (dose 40 mg, administration once) or placebo group (dose 1 placebo tablet, administration once), with 180 participants planned to be included in each group, for a total of about 360 participants.
- Conditions
- Respiratory Viral Infection
- Being tested
- ZX-7101A, Placebo
- Keywords
- adolescent, ZX-7101A
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ZX-7101ADrug
Day1 Take one tablet of ZX-7101A orally once (specification: 40mg/ tablet) with appropriate amount of warm water
PlaceboDrug
Day1 Take one tablet of Placebo orally once with appropriate amount of warm water
| Study group | Role | What they receive |
|---|---|---|
| ZX-7101A | Experimental | Before starting study treatment on day 1 (D1), eligible subjects were randomly assigned in a 1:1 ratio to receive either ZX-7101A (1 tablet，specification：40mg, single dose) or placebo (1 tablet, single dose).
A total of 360 subjects were planned to be enrolled in this study，in ZX-7101A group was planned to enroll about 180 subjects. Receives: Drug: ZX-7101A |
| Placebo group | Placebo comparator | Before starting study treatment on day 1 (D1), eligible subjects were randomly assigned in a 1:1 ratio to receive either ZX-7101A (1 tablet，specification：40mg, single dose) or placebo (1 tablet, single dose).
A total of 360 subjects were planned to be enrolled in this study，in placebo group was planned to enroll about 180 subjects. Receives: Drug: Placebo |
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)，nd the duration is at least 21.5 hours (approximately 24 hours -10%)
Measured: From accepting ZX-7101A until the 15 days after the first dosing
Secondary outcomes (4)
The time influenza RNA turns negative
Defined as the time from initiation of treatment until the first influenza viral RNA falls below the lower limit of quantification (measured by RT-PCR)
Measured: From accepting ZX-7101A until the 15 days after the first dosing
The time Virus Titer turns negative
Defined as the time from initiation of treatment until the first viral titer falls below the lower limit of quantification
Measured: From accepting ZX-7101A until the 15 days after the first dosing
Percentage of subjects with RT-PCR positive influenza virus RNA and measurable virus titer at each visit (unit: %)
the number of subjects with RT-PCR positive influenza virus RNA and measurable virus titer /The number of subjects
Measured: From accepting ZX-7101A until the 15 days after the first dosing
Time (in hours) for relief of 4 systemic symptoms (muscle or joint pain, weakness, headache, fever, or chills/sweating)
Symptom remission is defined as a score of 0 (asymptomatic) or 1 (mild) for all four of the above symptoms. The duration is at least 21.5 hours
(About 24 hours -10%)
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 posted25 Oct 2023
- Study start30 Nov 2023
- Primary completion13 Feb 2025
- Study completion13 Feb 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Respiratory Viral InfectionStudies 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
- Model description
- This is a multicenter, randomized, double-blind, placebo-controlled Phase III clinical study
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 361 participants (actual)
Sponsor and investigators
- Lead sponsor
- Nanjing Zenshine Pharmaceuticals
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06099873
- Sponsor's protocol ID
- ZX-7101A-207
- Acronym
- ZX-7101A-207
- Status last verified
- Feb 2025
- First submitted
- 19 Oct 2023
- Last updated
- 19 Feb 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.
Study at a glance
From the registry record, last updated by the sponsor on 19 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multicenter, Randomized, Double-blind, Placebo-controlled Phase III Trial of ZX-7101A Tablets to Evaluate the Efficacy and Safety in the Treatment of Uncomplicated Influenza in Adolescents
- ClinicalTrials.gov ID
- NCT06099873
- Acronym / sponsor ID
- ZX-7101A-207 / ZX-7101A-207
- Conditions
- Respiratory Viral Infection
- Keywords
- adolescent, ZX-7101A
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 361 participants (actual)
- Lead sponsor
- Nanjing Zenshine PharmaceuticalsIndustry (pharma, biotech, devices)
- Study start
- 30 Nov 2023 (actual)
- Primary completion
- 13 Feb 2025 (actual)
- Study completion
- 13 Feb 2025 (actual)
- First posted
- 25 Oct 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 primary object of this study is evaluating the efficacy of ZX-7101A tablets versus placebo in the treatment of uncomplicated simple influenza in adolescents.
The seongdary object is evaluating the safety of ZX-7101A tablet in the treatment of uncomplicated simple influenza in adolescents.
Detailed description
In this study, adolescents aged 12 and < 18 with uncomplicated influenza are selected as subjects. Typical systemic and/or respiratory influenza symptoms were required, and the time interval between the first onset of influenza symptoms and random enrollment was less than 48 hours. This study is divided into screening/treatment period (D1) and observation period (about 2 weeks). You will be eligible before starting study therapy on day 1 (D1). Participants were randomly assigned 1:1 to ZX-7101A group (dose 40 mg, administration once) or placebo group (dose 1 placebo tablet, administration once), with 180 participants planned to be included in each group, for a total of about 360 participants.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- This is a multicenter, randomized, double-blind, placebo-controlled Phase III clinical study
| Arm | Type | Receives |
|---|---|---|
| ZX-7101A | Experimental | Drug: ZX-7101ABefore starting study treatment on day 1 (D1), eligible subjects were randomly assigned in a 1:1 ratio to receive either ZX-7101A (1 tablet，specification：40mg, single dose) or placebo (1 tablet, single dose). A total of 360 subjects were planned to be enrolled in this study，in ZX-7101A group was planned to enroll about 180 subjects. |
| Placebo group | Placebo comparator | Drug: PlaceboBefore starting study treatment on day 1 (D1), eligible subjects were randomly assigned in a 1:1 ratio to receive either ZX-7101A (1 tablet，specification：40mg, single dose) or placebo (1 tablet, single dose). A total of 360 subjects were planned to be enrolled in this study，in placebo group was planned to enroll about 180 subjects. |
Who may qualify
- Ages
- 12 to 17 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (11 listed)
- 1.≥12 to<18 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.
Key exclusion criteria (9 listed)
- 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.
- 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 infections requiring systemic anti-infective treatment, or blood routine examination at screening: <13 years of age ：white blood cell count (WBC) > 11.3 × 109/L(venous blood);≥13 to<18 years of age ：white blood cell count (WBC) > 11.0 × 109/L(venous blood).
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-7101ADay1 Take one tablet of ZX-7101A orally once (specification: 40mg/ tablet) with appropriate amount of warm water | Drug | ZX-7101A |
| PlaceboDay1 Take one tablet of Placebo orally once with appropriate amount of warm water | Drug | Placebo 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)，nd the duration is at least 21.5 hours (approximately 24 hours -10%)
4 secondary outcomes
The time influenza RNA turns negative
Time frame: From accepting ZX-7101A until the 15 days after the first dosing
The time Virus Titer turns negative
Time frame: From accepting ZX-7101A until the 15 days after the first dosing
Percentage of subjects with RT-PCR positive influenza virus RNA and measurable virus titer at each visit (unit: %)
Time frame: From accepting ZX-7101A until the 15 days after the first dosing
Time (in hours) for relief of 4 systemic symptoms (muscle or joint pain, weakness, headache, fever, or chills/sweating)
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 19 Feb 2025.
- Individual participant dataSharing planned: No. The results of the trial will be used for New Drug Application.
Related trials for Respiratory Viral Infection
Not yet recruitingPhase 1
Phase I Open-Label Safety Trial of Pembrolizumab for Neurological Post- Acute Sequelae of SARS-CoV-2 (PD1-PASC I)
Post-Acute COVID-19 Syndrome
RecruitingObservational study
VIRal Pulmonary Infections in Older AGE
Viral Pulmonary Infections
Active, not recruitingPhase 1
A Safety and Immunogenicity Trial of OCU500, ChAd36 Vector Encoding SARS-CoV-2 Spike Vaccine Via Intranasal and Inhalational Routes in Previously Vaccinated Adults
COVID-19
RecruitingPhase 3
Study to Learn About a Respiratory Syncytial Virus Vaccine in Children at High Risk of RSV Disease
Respiratory Syncytial Virus (RSV)
Enrolling by invitation
Personalized Ventilator Settings for Patients on ECMO
Acute Respiratory Distress Syndrome (ARDS), Extracorporeal Membrane Oxygenation
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 ZX-7101A in people with Respiratory Viral Infection, 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 11 inclusion and 9 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 19 Feb 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?
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 19 Feb 2025.