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. (part of CSPC Pharmaceutical Group Limited) · Phase 2, Interventional, and Treatment
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.
2,356 studies on the registry are indexed under Influenza, Human; 184 are open to participants now.
This study's planned enrollment of 213 is close to the median of 227 across 1,957 interventional studies indexed under Influenza, Human.
Browse Influenza, Human studies →CSPC ZhongQi Pharmaceutical Technology Co., Ltd. is the lead sponsor of 167 studies on the registry; 47 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
At screening, meet all of the following:
Female participants must meet:
Exclusion Criteria:
Influenza virus infection requiring hospitalization (any of the following):
Any of the following severe case criteria:
Any critical case criteria:
High-risk groups for severe/critical cases (any of the following):
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Able to become pregnant: from the first period until menopause, unless permanently unable to through surgery (removal of the womb, or of both ovaries or both fallopian tubes).
Criteria for people of childbearing potential usually ask for a negative pregnancy test and for contraception during the study and for a time after it.
Periods have stopped for good: usually no period for 12 months in a row without another medical reason, sometimes confirmed by a blood test (FSH).
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Chronic obstructive pulmonary disease: long-term lung disease that makes it hard to breathe out, including emphysema and chronic bronchitis.
Two enzymes measured in a routine blood test of the liver. Higher levels can mean the liver is under strain or damaged. SGPT and SGOT are older names for ALT and AST.
Criteria usually give a limit as a multiple of the upper limit of normal (ULN), often higher when cancer has spread to the liver.
The top of the normal range for a blood test, as set by the laboratory that runs it. Each lab prints its own range next to your result.
“≤ 2.5 × ULN” means the result can be up to two and a half times that top value.
A yellow substance made when red blood cells are broken down, which the liver clears. A high level can mean a problem with the liver or the bile ducts.
Criteria often allow more for people with Gilbert’s syndrome, a harmless inherited condition that raises bilirubin.
The New York Heart Association’s four classes of how much heart failure limits physical activity.
Studies set their own limit — many outside heart failure leave out class III–IV, while heart failure studies may ask for a particular class. Check the class this study names.
Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.
On an ECG, the QT interval is the time the heart’s lower chambers take to activate electrically and recover in each beat. QTc is that time adjusted for heart rate (QTcF by Fridericia’s formula, QTcB by Bazett’s). Some medicines lengthen it, and a long QTc can raise the risk of a dangerous heart rhythm.
The study may name a correction formula and a limit in milliseconds, often around 450–480.
A recording of the heart’s electrical activity, taken with stickers on the chest, arms and legs. It takes a few minutes and does not hurt.
A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.
Read whether the line is about a condition or about medicines, and which medicines and doses it means.
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
The human immunodeficiency virus, which weakens the immune system.
Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
The other ingredients in a medicine besides the active drug, such as fillers, colours or preservatives.
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
Childbearing potential
Able to become pregnant: from the first period until menopause, unless permanently unable to through surgery (removal of the womb, or of both ovaries or both fallopian tubes).
Criteria for people of childbearing potential usually ask for a negative pregnancy test and for contraception during the study and for a time after it.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Postmenopausal
Periods have stopped for good: usually no period for 12 months in a row without another medical reason, sometimes confirmed by a blood test (FSH).
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraception
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
COPD
Chronic obstructive pulmonary disease: long-term lung disease that makes it hard to breathe out, including emphysema and chronic bronchitis.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
ALT and AST (liver enzymes)
Two enzymes measured in a routine blood test of the liver. Higher levels can mean the liver is under strain or damaged. SGPT and SGOT are older names for ALT and AST.
Criteria usually give a limit as a multiple of the upper limit of normal (ULN), often higher when cancer has spread to the liver.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
ULN (upper limit of normal)
The top of the normal range for a blood test, as set by the laboratory that runs it. Each lab prints its own range next to your result.
“≤ 2.5 × ULN” means the result can be up to two and a half times that top value.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Bilirubin
A yellow substance made when red blood cells are broken down, which the liver clears. A high level can mean a problem with the liver or the bile ducts.
Criteria often allow more for people with Gilbert’s syndrome, a harmless inherited condition that raises bilirubin.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
NYHA class (heart failure)
The New York Heart Association’s four classes of how much heart failure limits physical activity.
Studies set their own limit — many outside heart failure leave out class III–IV, while heart failure studies may ask for a particular class. Check the class this study names.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Clinically significant
Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
QT and QTc
On an ECG, the QT interval is the time the heart’s lower chambers take to activate electrically and recover in each beat. QTc is that time adjusted for heart rate (QTcF by Fridericia’s formula, QTcB by Bazett’s). Some medicines lengthen it, and a long QTc can raise the risk of a dangerous heart rhythm.
The study may name a correction formula and a limit in milliseconds, often around 450–480.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
ECG (electrocardiogram)
A recording of the heart’s electrical activity, taken with stickers on the chest, arms and legs. It takes a few minutes and does not hurt.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Immunosuppression
A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.
Read whether the line is about a condition or about medicines, and which medicines and doses it means.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Cancer (malignancy)
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
HIV
The human immunodeficiency virus, which weakens the immune system.
Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
BMI (body mass index)
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Excipients
The other ingredients in a medicine besides the active drug, such as fillers, colours or preservatives.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Investigational drug or device
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Eligible participants will receive one 40-mg SYH2085 tablet and one placebo tablet orally on Day 1.
Drug: SYH2085 · Drug: Placebo
Eligible participants will receive two 40-mg SYH2085 tablets orally on Day 1.
Drug: SYH2085
Eligible participants will receive two SYH2085 placebo tablets orally on Day 1.
Drug: Placebo
One or two 40-mg SYH2085 tablets taken orally
One or two placebo tablets taken orally
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
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
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
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
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
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
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
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
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
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
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
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
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
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
Body temperature at each visit (°C)
Body temperature will be self-measured and recorded by participants every daily.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: Up to Day22
Pharmacokinetics (plasma concentrations)
Plasma concentrations of SYH2085 active metabolite SYH2085A-01207 will be measured.
Time frame: Up to Day22
Pharmacokinetics (Cmax)
The pharmacokinetics parameters Cmax will be calculated.
Time frame: Up to Day22
Pharmacokinetics (AUC0-t)
The pharmacokinetics parameters AUC0-t will be calculated.
Time frame: Up to Day22
Pharmacokinetics (AUC0-∞)
The pharmacokinetics parameters AUC0-∞ will be calculated.
Time frame: Up to Day22
Pharmacokinetics (Tmax)
The pharmacokinetics parameters Tmax will be calculated.
Time frame: Up to Day22
Pharmacokinetics (CL/F)
The pharmacokinetics parameters CL/F will be calculated.
Time frame: Up to Day22
Pharmacokinetics (Vz/F)
The pharmacokinetics parameters Vz/F will be calculated.
Time frame: Up to Day22
Pharmacokinetics (t1/2)
The pharmacokinetics parameters t1/2 will be calculated.
Time frame: 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.
Time frame: Up to Day22
No study locations are listed for this record.
Start is estimated for Oct 2026; primary completion for Apr 2027, 6 months later.
Of 86 industry-sponsored phase 2 interventional studies under Influenza, Human, half reached primary completion within 7 months of starting (the median), counting those still running; a quarter within 5 and three quarters within 14. This study's planned 6 months is below that.
Counting every sponsor, half of 122 studies reached it within 10 months; a quarter within 5 and three quarters within 19.
How these figures are worked out, and which studies are left out of them.
This study is not yet recruiting, as verified in Jul 2026. You cannot join it, but the record below documents what was studied.
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CSPC ZhongQi Pharmaceutical Technology Co., Ltd. →