Can a new pill shorten the flu?
NCT ID NCT07798193
First seen Sep 01, 2026 · Last updated Sep 02, 2026 · Updated 1 time
Summary
Researchers are testing an experimental oral drug called SYH2085 in adults with uncomplicated influenza. The study compares SYH2085 against a placebo to see if it can shorten the time to resolution of flu symptoms like fever, cough, and body aches. Participants must have tested positive for the flu and started symptoms within 48 hours. The trial also measures how quickly the virus clears from the body.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- SYH2085 tablets
- What this could lead to
- If SYH2085 works, it could offer a new oral treatment to shorten flu illness and reduce how long people shed the virus.
- What could go wrong
- This is an early Phase 2 study, so the drug may not prove effective or safe. Results from this small group may not apply to everyone.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
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Phase 2
Tests whether the treatment actually works, and watches for side effects, in a larger group.
- Participants
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About 213 people
The number the study aims to enrol. It can still change while the study runs.
- Expected to start
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Oct 2026
An estimate. Start dates often move.
- Expected to finish
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Jun 2027
An estimate. End dates often move.
- Lead sponsor
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A company
The lead sponsor is a pharmaceutical, biotech, or medical-device company.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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18 years and older
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
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: * 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.
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
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