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Not yet recruitingNCT07798193Updated Sep 1, 2026

A Study of SYH2085 Tablets Compared With Placebo in Chinese Adult Patients With Uncomplicated Influenza.

A Phase 2 interventional study of SYH2085 and Placebo in Influenza, sponsored by CSPC ZhongQi Pharmaceutical Technology Co., Ltd.. Not yet recruiting. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-09-01.

Sponsored by CSPC ZhongQi Pharmaceutical Technology Co., Ltd. · Phase 2, Interventional, and Treatment

Phase
Phase 2
Study type
Interventional
Enrollment
213
Allocation
Randomized
Ages
18 Years and older
Sex
All
01

Study 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. The study plans to enroll patients with typical systemic and respiratory influenza symptoms, with symptom onset ≤48 hours.

02

Conditions studied

  • Influenza

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03

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  • Age ≥18 years at time of signing ICF.

  • At screening, meet all of the following:

    1. Positive influenza antigen test or influenza virus nucleic acid test (other rapid molecular diagnostic methods are acceptable).
    2. Axillary temperature ≥37.3°C at screening; if antipyretics have been taken, axillary temperature ≥37.3°C at least 4 hours after dosing;
    3. At least one systemic influenza symptom of moderate or greater severity: muscle/joint aches, fatigue, headache, fever/chills;
    4. At least one respiratory influenza symptom of moderate or greater severity: nasal congestion, sore throat, cough.
  • Time from onset of first influenza symptom to randomization ≤48 hours.

  • Female participants must meet:

    1. Not of childbearing potential (i.e., hysterectomy, bilateral oophorectomy, documented ovarian failure, or postmenopausal defined as >50 years and amenorrhea ≥12 months), or
    2. 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.

Exclusion criteria

Exclusion Criteria:

  • Influenza virus infection requiring hospitalization (any of the following):

    1. Significant exacerbation of underlying diseases, e.g., COPD, diabetes, chronic heart failure, chronic renal failure, cirrhosis, etc.

    2. Any of the following severe case criteria:

      1. Respiratory rate ≥30/min;
      2. Oxygen saturation ≤93% on room air at rest;
      3. PaO2/FiO2 ≤300; for high-altitude areas (>1000 m), correction: PaO2/FiO2 × [760/atmospheric pressure (mmHg)] (1 mmHg=0.133 kPa);
      4. Progressive clinical deterioration with lung imaging showing >50% lesion progression within 24-48 hours.

    3. Any critical case criteria:

      1. Respiratory failure requiring mechanical ventilation;
      2. Shock;
      3. Acute necrotizing encephalopathy;
      4. Other organ failure requiring ICU monitoring.

  • High-risk groups for severe/critical cases (any of the following):

    1. 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.;
    2. Clinically significant corrected QT interval abnormality on ECG (QTc >450 ms for males or >470 ms for females, QTcF by Fridericia formula);
    3. 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.
    4. Concurrent conditions requiring aspirin or salicylate therapy;
    5. 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.
04

Study design

Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Quadruple (Participant, Care provider, Investigator, Outcomes assessor)
Enrollment
213 participants (estimated)

Study arms

  • Experimental
    SYH2085 40 mg

    Eligible participants will receive one 40-mg SYH2085 tablet and one placebo tablet orally on Day 1.

    Drug: SYH2085 · Drug: Placebo

  • Experimental
    SYH2085 80 mg

    Eligible participants will receive two 40-mg SYH2085 tablets orally on Day 1.

    Drug: SYH2085

  • Placebo comparator
    Placebo

    Eligible participants will receive two SYH2085 placebo tablets orally on Day 1.

    Drug: Placebo

Interventions

  • DrugSYH2085

    One or two 40-mg SYH2085 tablets taken orally

  • DrugPlacebo

    One or two placebo tablets taken orally

05

What researchers measure

Primary outcomes

  1. 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%).

    Time frame: Up to Day22

Secondary outcomes

  1. 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).

    Time frame: Up to Day22

  2. 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.

    Time frame: Up to Day22

  3. 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.

    Time frame: Up to Day22

  4. 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.

    Time frame: Up to Day22

  5. 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.

    Time frame: Up to Day22

  6. 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.

    Time frame: Up to Day22

  7. 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%).

    Time frame: Up to Day22

  8. 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.

    Time frame: Up to Day22

  9. 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.

    Time frame: Up to Day22

  10. 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.

    Time frame: Up to Day22

  11. 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.

    Time frame: Up to Day22

  12. 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.

    Time frame: Up to Day22

  13. 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.

    Time frame: Up to Day22

  14. Body temperature at each visit (°C)

    Body temperature will be self-measured and recorded by participants every daily.

    Time frame: Up to Day22

  15. 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.

    Time frame: Up to Day22

  16. 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.

    Time frame: Up to Day22

  17. 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.

    Time frame: Up to Day22

  18. Pharmacokinetics (plasma concentrations)

    Plasma concentrations of SYH2085 active metabolite SYH2085A-01207 will be measured.

    Time frame: Up to Day22

  19. Pharmacokinetics (Cmax)

    The pharmacokinetics parameters Cmax will be calculated.

    Time frame: Up to Day22

  20. Pharmacokinetics (AUC0-t)

    The pharmacokinetics parameters AUC0-t will be calculated.

    Time frame: Up to Day22

  21. Pharmacokinetics (AUC0-∞)

    The pharmacokinetics parameters AUC0-∞ will be calculated.

    Time frame: Up to Day22

  22. Pharmacokinetics (Tmax)

    The pharmacokinetics parameters Tmax will be calculated.

    Time frame: Up to Day22

  23. Pharmacokinetics (CL/F)

    The pharmacokinetics parameters CL/F will be calculated.

    Time frame: Up to Day22

  24. Pharmacokinetics (Vz/F)

    The pharmacokinetics parameters Vz/F will be calculated.

    Time frame: Up to Day22

  25. Pharmacokinetics (t1/2)

    The pharmacokinetics parameters t1/2 will be calculated.

    Time frame: Up to Day22

  26. 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.

    Time frame: Up to Day22

06

Study locations

No study locations are listed for this record.

07

Registry details

Key details

Study ID
NCT07798193
Lead sponsor
CSPC ZhongQi Pharmaceutical Technology Co., Ltd.
Responsible party
Sponsor
First posted
Sep 1, 2026
Start date
Oct 10, 2026 (estimated)
Primary completion
Apr 30, 2027 (estimated)
Completion
Jun 30, 2027 (estimated)
Last update
Sep 1, 2026

Study contacts

Clinical Trials Information Group officer
Contact
ctr-contact@cspc.cn
86-31169085587

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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