InfluenzaPhase 2NCT07798193
A Study of SYH2085 Tablets Compared With Placebo in Chinese Adult Patients With Uncomplicated Influenza.
A Phase 2 study testing SYH2085 in people with Influenza, run by CSPC ZhongQi Pharmaceutical Technology Co., Ltd..
Trial summary
This is a multicenter, randomized, double-blind, placebo-controlled Phase II study to evaluate the efficacy and safety of SYH2085 tablets compared with placebo in Chinese adult participants with uncomplicated influenza. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Influenza
- What is being tested?
- SYH2085
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 213 participants
- Where
- No sites listed yet
- Study dates
- 10 Oct 2026to 30 Jun 2027
- Phase
- Phase 2
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age ≥18 years at time of signing ICF.
- At screening, meet all of the following:
- Positive influenza antigen test or influenza virus nucleic acid test (other rapid molecular diagnostic methods are acceptable).
- Axillary temperature ≥37.3°C at screening; if antipyretics have been taken, axillary temperature ≥37.3°C at least 4 hours after dosing;
- At least one systemic influenza symptom of moderate or greater severity: muscle/joint aches, fatigue, headache, fever/chills;
- At least one respiratory influenza symptom of moderate or greater severity: nasal congestion, sore throat, cough.
Show all 13Show fewer
- Time from onset of first influenza symptom to randomization ≤48 hours.
- Female participants must meet:
- Not of childbearing potential (i.e., hysterectomy, bilateral oophorectomy, documented ovarian failure, or postmenopausal defined as >50 years and amenorrhea ≥12 months), or
- Of childbearing potential, with negative pregnancy test at screening, and not pregnant, peripartum, or breastfeeding.
- Participants and their partners agree to complete abstinence or use effective contraception from screening until 1 month after study completion.
- Male participants agree not to donate sperm from screening until 1 month after study completion.
- Understand and voluntarily sign ICF, willing and able to comply with all study procedures, and able to complete the participant diary as required.
Who cannot join
- Influenza virus infection requiring hospitalization (any of the following):
- Significant exacerbation of underlying diseases, e.g., COPD, diabetes, chronic heart failure, chronic renal failure, cirrhosis, etc.
- Any of the following severe case criteria:
- Respiratory rate ≥30/min;
- Oxygen saturation ≤93% on room air at rest;
- PaO2/FiO2 ≤300; for high-altitude areas (>1000 m), correction: PaO2/FiO2 × [760/atmospheric pressure (mmHg)] (1 mmHg=0.133 kPa);
Show all 33Show fewer
- Progressive clinical deterioration with lung imaging showing >50% lesion progression within 24-48 hours.
- Any critical case criteria:
- Respiratory failure requiring mechanical ventilation;
- Shock;
- Acute necrotizing encephalopathy;
- Other organ failure requiring ICU monitoring.
- High-risk groups for severe/critical cases (any of the following):
- Severe or poorly controlled underlying diseases, e.g., COPD, liver disease (ALT or AST ≥3×ULN, total bilirubin ≥1.5×ULN), chronic kidney disease (serum creatinine >177 μmol/L or 2 mg/dL), severe hematological disorders, chronic congestive heart failure (NYHA class III-IV), neurological and neuromuscular diseases, metabolic diseases, etc.;
- Clinically significant corrected QT interval abnormality on ECG (QTc >450 ms for males or >470 ms for females, QTcF by Fridericia formula);
- Immunocompromised patients, e.g., malignancy, organ or bone marrow transplantation, HIV infection, or use of immunosuppressants within 3 months; Note: Participants with basal cell carcinoma, localized squamous cell carcinoma of skin, or cervical carcinoma in situ may be enrolled if curative treatment completed ≥12 months before ICF; other malignancies if curative treatment completed ≥5 years before ICF.
- Concurrent conditions requiring aspirin or salicylate therapy;
- Obesity (BMI >30 kg/m²).
- Bronchitis, pneumonia, pleural effusion, or interstitial lung disease suspected by a clinician at screening, or confirmed by chest imaging (X-ray / CT) and judged by investigator at screening.
- Acute respiratory infection, otitis media, or sinusitis within 2 weeks before screening.
- Concurrent infection requiring systemic anti-infective therapy, or WBC >10.0×10⁹/L at screening.
- Purulent sputum or suppurative tonsillitis.
- Difficulty swallowing medication or history of gastrointestinal diseases that significantly affect drug absorption (including but not limited to reflux esophagitis, chronic diarrhea, inflammatory bowel disease, intestinal tuberculosis, gastroinoma, short-bowel syndrome, post-gastrectomy, etc.).
- History of allergy to active ingredient or excipients of the study drug.
- Previous exposure to SYH2085.
- Body weight <40 kg.
- Use of anti-influenza drugs within 7 days before screening (including but not limited to neuraminidase inhibitors, hemagglutinin inhibitors, M2 ion channel blockers, and CEN inhibitors, e.g., oseltamivir, zanamivir, peramivir, laninamivir, umifenovir, favipiravir, rimantadine, amantadine, arbidol, nitazoxanide, baloxavir marboxil, marboxil, etc.).
- Influenza vaccination within 6 months before screening.
- History of alcohol abuse within 3 months before screening (males >14 units/week, females >7 units/week; 1 unit = 10 g pure alcohol), or alcohol consumption within 48 hours before dosing, or history of drug abuse.
- Use of any prohibited medications within 2 weeks / 5 half-lives (whichever longer; excluding anti-influenza drugs) before screening and during the planned trial period.
- Participation in any clinical trial of investigational drug, biologic, or medical device within 30 days (or 5 half-lives, whichever longer) before screening.
- Positive SARS-CoV-2 antigen or nucleic acid test.
- Any other condition judged by the investigator as unsuitable for participation.
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: A Multicenter, Randomized, Double-Blind, Placebo-Controlled Phase II Clinical Study to Preliminarily Evaluate the Efficacy and Safety of SYH2085 Tablets in Chinese Adult Participants With Uncomplicated Influenza
This is a multicenter, randomized, double-blind, placebo-controlled Phase II study to evaluate the efficacy and safety of SYH2085 tablets compared with placebo in Chinese adult participants with uncomplicated influenza. The study plans to enroll patients with typical systemic and respiratory influenza symptoms, with symptom onset ≤48 hours.
- Conditions
- Influenza
- Being tested
- SYH2085, Placebo
- Medical subject headings
- Influenza, Human
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SYH2085Drug
One or two 40-mg SYH2085 tablets taken orally
PlaceboDrug
One or two placebo tablets taken orally
| Study group | Role | What they receive |
|---|---|---|
| SYH2085 40 mg | Experimental | Eligible participants will receive one 40-mg SYH2085 tablet and one placebo tablet orally on Day 1. Receives: Drug: SYH2085; Drug: Placebo |
| SYH2085 80 mg | Experimental | Eligible participants will receive two 40-mg SYH2085 tablets orally on Day 1. Receives: Drug: SYH2085 |
| Placebo | Placebo comparator | Eligible participants will receive two SYH2085 placebo tablets orally on Day 1. Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Time to resolution of all influenza symptoms (hours)
Time to resolution of all influenza symptoms (hours) is defined as the time from start of study treatment to resolution of all influenza symptoms. Resolution of all influenza symptoms. is defined as all 7 influenza symptoms (headache, fever/chills, muscle/joint aches, fatigue, cough, nasal congestion, sore throat) rated as 2 or 3 becoming 0 (absent) or 1 (mild), and all clinical symptoms rated as 0 or 1 remaining resolved; with duration of resolution at least 21.5 hours (approximately 24 hours minus 10%).
Measured: Up to Day22
Secondary outcomes (26)
Time to influenza virus RNA negativity (hours)
Time to influenza virus RNA negativity (hours) is defined as time from start of study treatment to first influenza virus RNA below the lower limit of detection (by RT-PCR).
Measured: Up to Day22
Time to influenza virus titer negativity (hours)
Time to influenza virus titer negativity (hours) is defined as time from start of study treatment to first virus titer below the lower limit of quantification.
Measured: Up to Day22
Change from baseline in influenza virus RNA (log10 copies/mL) at each visit
Nasopharyngeal swabs will be collected from participants at the study center and sent to the central laboratory for quantitation of viral RNA load.
Measured: Up to Day22
Change from baseline in influenza virus and virus titer (log10 TCID50/mL) at each visit
Nasopharyngeal swabs will be collected from participants at the study center and sent to the central laboratory for quantitation of viral titer.
Measured: Up to Day22
Viral load AUC and virus titer AUC
Viral load AUC is defined as AUC of change from baseline in the amount of virus RNA (RT-PCR) from Day 1 to Day 22. Virus titer AUC is defined as AUC of change from baseline in the virus titer from Day 1 to Day 22.
Measured: Up to Day22
Percentage of participants with RT-PCR-positive influenza virus RNA and detectable virus titer at each visit (%)
RT-PCR-positive influenza virus RNA is defined as the amount of virus RNA not less than the lower limit of detection (by RT-PCR); detectable virus titer is defined as virus titer not less than the lower limit of quantification.
Measured: Up to Day22
Percentage of participants with resolution of all influenza symptoms at each visit (%)
Resolution of all influenza symptom is defined as all 7 influenza symptoms (headache, fever/chills, muscle/joint aches, fatigue, cough, nasal congestion, sore throat) rated as 2 or 3 becoming 0 (absent) or 1 (mild), and all clinical symptoms rated as 0 or 1 remaining resolved; with duration of resolution at least 21.5 hours (approximately 24 hours minus 10%).
Measured: Up to Day22
Time to resolution of 4 systemic symptoms (headache, fever/chills, muscle/joint aches, fatigue) (hours)
Time to resolution of 4 systemic symptoms is defined as the time from start of study treatment to resolution of 4 systemic symptoms.
Measured: Up to Day22
Time to resolution of 3 respiratory symptoms (cough, nasal congestion, sore throat) (hours)
Time to resolution of 3 respiratory symptoms is defined as the time from start of study treatment to resolution of 3 respiratory symptoms.
Measured: Up to Day22
Time to resolution of each influenza symptom (hours)
Time to resolution of each influenza symptoms is defined as the time from the start of treatment to resolution of the influenza symptoms.
Measured: Up to Day22
Change from baseline in composite influenza symptom score at each visit
The composite symptom score is the total score of the 7 influenza symptoms as assessed by the participants, and ranges from 0 to 21.
Measured: Up to Day22
Time to resolution of fever (hours)
Time to resolution of fever was defined as the time between the initiation of the study treatment and the resolution of fever.
Measured: Up to Day22
Percentage of participants reporting normal temperature at each visit (%)
Participants reporting normal temperature is defined as those with axillary temperature dropping to less than 37°C after the initiation of study treatment.
Measured: Up to Day22
Body temperature at each visit (°C)
Body temperature will be self-measured and recorded by participants every daily.
Measured: Up to Day22
Percentage of influenza-related complications (hospitalization, death, sinusitis, bronchitis, otitis media, and radiologically confirmed pneumonia) (%)
Participants will be assessed by the investigations prior to dosing and during the study period.
Measured: Up to Day22
Percentage of participants using concomitant acetaminophen (%) and frequency of use
Acetaminophen will be provided as a rescue medication. If the investigator determines that the participant's influenza symptoms require treatment with acetaminophen, the participant should record the time and dose of administration.
Measured: Up to Day22
Percentage of participants with adverse events (AEs)
Any abnormalities in vital signs, physical examinations, laboratory tests, 12-lead electrocardiograms (ECGs), or other parameters observed in participants post-dose will be recorded as AEs.
Measured: Up to Day22
Pharmacokinetics (plasma concentrations)
Plasma concentrations of SYH2085 active metabolite SYH2085A-01207 will be measured.
Measured: Up to Day22
Pharmacokinetics (Cmax)
The pharmacokinetics parameters Cmax will be calculated.
Measured: Up to Day22
Pharmacokinetics (AUC0-t)
The pharmacokinetics parameters AUC0-t will be calculated.
Measured: Up to Day22
Pharmacokinetics (AUC0-∞)
The pharmacokinetics parameters AUC0-∞ will be calculated.
Measured: Up to Day22
Pharmacokinetics (Tmax)
The pharmacokinetics parameters Tmax will be calculated.
Measured: Up to Day22
Pharmacokinetics (CL/F)
The pharmacokinetics parameters CL/F will be calculated.
Measured: Up to Day22
Pharmacokinetics (Vz/F)
The pharmacokinetics parameters Vz/F will be calculated.
Measured: Up to Day22
Pharmacokinetics (t1/2)
The pharmacokinetics parameters t1/2 will be calculated.
Measured: Up to Day22
Change from baseline in influenza virus RNA (log10 copies/mL) and virus titer (log10 TCID50/mL) at each visit
Nasopharyngeal swabs will be collected from participants at the study center and sent to the central laboratory for quantitation of viral RNA load and viral titer.
Measured: Up to Day22
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Sep 2026
- Study start10 Oct 2026 (estimated)
- Primary completion30 Apr 2027 (estimated)
- Study completion30 Jun 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for InfluenzaStudies of the same condition, open and under way.
- More trials run by CSPC ZhongQi Pharmaceutical Technology Co., Ltd.The sponsor's other registered studies.
- 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
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- multicenter, randomized, parallel-group, placebo-controlled study
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 213 participants (estimated)
Sponsor and investigators
- Lead sponsor
- CSPC ZhongQi Pharmaceutical Technology Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07798193
- Sponsor's protocol ID
- SYH2085-002
- Status last verified
- Jul 2026
- First submitted
- 25 Aug 2026
- Last updated
- 1 Sep 2026
- 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 1 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multicenter, Randomized, Double-Blind, Placebo-Controlled Phase II Clinical Study to Preliminarily Evaluate the Efficacy and Safety of SYH2085 Tablets in Chinese Adult Participants With Uncomplicated Influenza
- ClinicalTrials.gov ID
- NCT07798193
- Acronym / sponsor ID
- SYH2085-002
- Conditions
- Influenza
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 213 participants (estimated)
- Lead sponsor
- CSPC ZhongQi Pharmaceutical Technology Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- 10 Oct 2026 (estimated)
- Primary completion
- 30 Apr 2027 (estimated)
- Study completion
- 30 Jun 2027 (estimated)
- First posted
- 1 Sep 2026 (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 is a multicenter, randomized, double-blind, placebo-controlled Phase II study to evaluate the efficacy and safety of SYH2085 tablets compared with placebo in Chinese adult participants with uncomplicated influenza. The study plans to enroll patients with typical systemic and respiratory influenza symptoms, with symptom onset ≤48 hours.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 3
- Model description
- multicenter, randomized, parallel-group, placebo-controlled study
| Arm | Type | Receives |
|---|---|---|
| SYH2085 40 mg | Experimental | Drug: SYH2085, Drug: PlaceboEligible participants will receive one 40-mg SYH2085 tablet and one placebo tablet orally on Day 1. |
| SYH2085 80 mg | Experimental | Drug: SYH2085Eligible participants will receive two 40-mg SYH2085 tablets orally on Day 1. |
| Placebo | Placebo comparator | Drug: PlaceboEligible participants will receive two SYH2085 placebo tablets orally on Day 1. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (13 listed)
- Age ≥18 years at time of signing ICF.
- At screening, meet all of the following:
- Time from onset of first influenza symptom to randomization ≤48 hours.
- Female participants must meet:
- Participants and their partners agree to complete abstinence or use effective contraception from screening until 1 month after study completion.
Key exclusion criteria (33 listed)
- Influenza virus infection requiring hospitalization (any of the following):
- High-risk groups for severe/critical cases (any of the following):
- Bronchitis, pneumonia, pleural effusion, or interstitial lung disease suspected by a clinician at screening, or confirmed by chest imaging (X-ray / CT) and judged by investigator at screening.
- Acute respiratory infection, otitis media, or sinusitis within 2 weeks before screening.
- Concurrent infection requiring systemic anti-infective therapy, or WBC >10.0×10⁹/L at screening.
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 |
|---|---|---|
| SYH2085One or two 40-mg SYH2085 tablets taken orally | Drug | SYH2085 40 mg, SYH2085 80 mg |
| PlaceboOne or two placebo tablets taken orally | Drug | Placebo, SYH2085 40 mg |
Primary outcome
Time to resolution of all influenza symptoms (hours)
Time frame: Up to Day22
Time to resolution of all influenza symptoms (hours) is defined as the time from start of study treatment to resolution of all influenza symptoms. Resolution of all influenza symptoms. is defined as all 7 influenza symptoms (headache, fever/chills, muscle/joint aches, fatigue, cough, nasal congestion, sore throat) rated as 2 or 3 becoming 0 (absent) or 1 (mild), and all clinical symptoms rated as 0 or 1 remaining resolved; with duration of resolution at least 21.5 hours (approximately 24 hours minus 10%).
26 secondary outcomes
Time to influenza virus RNA negativity (hours)
Time frame: Up to Day22
Time to influenza virus titer negativity (hours)
Time frame: Up to Day22
Change from baseline in influenza virus RNA (log10 copies/mL) at each visit
Time frame: Up to Day22
Change from baseline in influenza virus and virus titer (log10 TCID50/mL) at each visit
Time frame: Up to Day22
Viral load AUC and virus titer AUC
Time frame: Up to Day22
Percentage of participants with RT-PCR-positive influenza virus RNA and detectable virus titer at each visit (%)
Time frame: Up to Day22
Percentage of participants with resolution of all influenza symptoms at each visit (%)
Time frame: Up to Day22
Time to resolution of 4 systemic symptoms (headache, fever/chills, muscle/joint aches, fatigue) (hours)
Time frame: Up to Day22
Time to resolution of 3 respiratory symptoms (cough, nasal congestion, sore throat) (hours)
Time frame: Up to Day22
Time to resolution of each influenza symptom (hours)
Time frame: Up to Day22
Change from baseline in composite influenza symptom score at each visit
Time frame: Up to Day22
Time to resolution of fever (hours)
Time frame: Up to Day22
Percentage of participants reporting normal temperature at each visit (%)
Time frame: Up to Day22
Body temperature at each visit (°C)
Time frame: Up to Day22
Percentage of influenza-related complications (hospitalization, death, sinusitis, bronchitis, otitis media, and radiologically confirmed pneumonia) (%)
Time frame: Up to Day22
Percentage of participants using concomitant acetaminophen (%) and frequency of use
Time frame: Up to Day22
Percentage of participants with adverse events (AEs)
Time frame: Up to Day22
Pharmacokinetics (plasma concentrations)
Time frame: Up to Day22
Pharmacokinetics (Cmax)
Time frame: Up to Day22
Pharmacokinetics (AUC0-t)
Time frame: Up to Day22
Pharmacokinetics (AUC0-∞)
Time frame: Up to Day22
Pharmacokinetics (Tmax)
Time frame: Up to Day22
Pharmacokinetics (CL/F)
Time frame: Up to Day22
Pharmacokinetics (Vz/F)
Time frame: Up to Day22
Pharmacokinetics (t1/2)
Time frame: Up to Day22
Change from baseline in influenza virus RNA (log10 copies/mL) and virus titer (log10 TCID50/mL) at each visit
Time frame: Up to Day22
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 1 Sep 2026.
Related trials for Influenza
Enrolling by invitation
Personalized Ventilator Settings for Patients on ECMO
Acute Respiratory Distress Syndrome (ARDS), Extracorporeal Membrane Oxygenation
RecruitingPhase 2
BPL-1357 Against H1N1 Influenza Virus Challenge
Influenza, Human
Not yet recruitingPhase 1
Safety and Immunogenicity of Chimeric Hemagglutinin mRNA Vaccine Candidates
Influenza
RecruitingPhase 1
pH1N1 Blinded Challenge Study
Influenza
RecruitingPhase 3
A Study to Evaluate the Safety and Efficacy of MK-1406/CD388 for Prevention of Influenza (MK-1406-005/CD388.SQ.3.06)
Influenza
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.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing SYH2085 in people with Influenza, run by CSPC ZhongQi Pharmaceutical Technology Co., Ltd..
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 13 inclusion and 33 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: opening soon, as of the sponsor's last update on 1 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
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 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?
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?
Contact Clinical Trials Information Group officer (86-31169085587, ctr-contact@cspc.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Time to resolution of all influenza symptoms (hours) (time frame: Up to Day22). 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 1 Sep 2026.