New drug SYH2085 tested in healthy people for first time
NCT ID NCT07412353
First seen Jun 27, 2026 · Last updated Jun 27, 2026
Summary
This Phase 1 trial is testing a new drug called SYH2085 in 74 healthy Chinese adults to see if it is safe and how the body processes it. Participants receive either a single dose of SYH2085 or a placebo, and the study also looks at how food affects the drug. This is an early step to gather safety information before testing the drug in people with a medical condition.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- SYH2085 (oral tablet)
- What this could lead to
- If successful, this early study will show that SYH2085 is safe enough to test in people with a disease, but it does not aim to treat any condition yet.
- What could go wrong
- This is a very early Phase 1 trial in only 74 healthy volunteers. It is designed to check safety, not effectiveness, so most drugs at this stage never become treatments.
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 1
The first testing in people. Mainly checks safety and dose, usually in a small group.
- Participants
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About 74 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Jan 2026
- Expected to finish
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Dec 2026
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 to 45 years
- Sex
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Anyone
- Healthy volunteers
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Accepted
You do not need to have the condition being studied to take part.
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: 1. Age of 18 - 45 years (inclusive), male or female; BMI: 19.0-28.0 kg/m\^2 (inclusive), with a minimum weight of 50.0 kg (inclusive) for male and 45.0 kg (inclusive) for female; 2. Normal vital signs; Normal physical examination; Normal ECG findings; Normal laboratory examination; Normal imaging examination (X-ray); 3. Participants and their partners agree to use effective and reliable contraceptive methods to avoid pregnancy, and male subjects had no plans to donate sperm, and female subjects had no plans to donate eggs, from the time they signed the informed consent to 3 months after the end of the study; 4. Participants must give informed consent before the trial, fully understand the content, procedures and possible adverse reactions, and voluntarily sign a written informed consent. Exclusion Criteria: 1. History of hypersensitivity or allergy to drug or food, or any component of the study drug; 2. Participants with a history of serious diseases, including pancreas, cardiovascular, liver, kidney, blood and lymphatic, central nervous system, and gastrointestinal systems, or other important diseases that may affect the absorption, metabolism, or excretion of the study drug; 3. History of gastrointestinal surgery or resection that may alter the absorption and/or elimination of orally administered drugs (except for appendectomy); 4. Participants who have undergone any surgical procedure within 6 months prior to the trial; 5. Participants with a history of respiratory or systemic acute infection within 2 weeks prior to screening; 6. Participants who have experienced blood loss exceeding 400 mL (e.g., due to blood donation or other reasons) within 3 months prior to the trial; 7. Participants who have participated in another investigational drug study within 3 months prior to the planned administration of the study drug, where the last dose was received less than 3 months before screening for this trial; or subjects who plan to participate in another drug trial during the course of this study; 8. Participants who have been vaccinated within 28 days prior to screening or plan to receive vaccination during the trial period; 9. Participants who have taken any prescription drugs, over-the-counter (OTC) medications, Chinese patent medicines, herbal medicines, health supplements, or oral supplements (e.g., calcium, iron, magnesium, selenium, zinc, etc.) within 28 days prior to screening or during the trial period; 10. Participants who have used oral long-acting contraceptives or implanted long-acting contraceptives within 28 days prior to screening; 11. Participants who have used any known inducers or inhibitors of hepatic enzymes (e.g., grapefruit, orange juice, etc.) within 28 days prior to screening or during the trial period; 12. Participants with any electrocardiogram (ECG) abnormality considered clinically significant by the investigator, including but not limited to: QTcF interval ≥450 ms, or a history of QTcF interval prolongation; PR interval ≥210 ms; QRS duration ≥120 ms; or a history of arrhythmia, syncope related to arrhythmia, use of a cardiac pacemaker, or other cardiac-related conditions. Note: Conditions include but are not limited to: heart failure; hypokalemia; atrial fibrillation, atrial flutter, premature atrial contractions, premature ventricular contractions, non-sustained or sustained ventricular tachycardia; bradycardia or sick sinus syndrome; personal or family history of any cardiac conduction abnormalities; personal or family history of Long QT Syndrome (LQTS); or family history of sudden death; 13. Participants with one or more abnormal vital signs at screening: aural temperature \>37.5°C, pulse rate \>100 beats per minute, systolic blood pressure ≥140 mmHg or \<90 mmHg, diastolic blood pressure ≥90 mmHg or \<50 mmHg; 14. Participants who smoked an average of more than 5 cigarettes per day within 3 months prior to screening, or who are unable to discontinue the use of any tobacco products during the trial period; 15. Participants who habitually consumed excessive amounts of xanthine- or caffeine-containing foods, beverages, or other items that may affect drug absorption, distribution, metabolism, or excretion within 1 month prior to screening and are unwilling to abstain during the trial. Examples include: coffee (\>1100 mL daily), tea (\>2200 mL daily), cola (\>2200 mL daily), energy drinks (\>1100 mL daily), chocolate (\>510 g daily); 16. Participants with alcohol abuse: alcohol consumption exceeding 14 units per week within 1 month prior to signing the informed consent form (1 unit = 285 mL of beer, 25 mL of spirits, or 150 mL of wine); 17. Participants with a positive alcohol breath test (\>0 mg/100 mL) or those unable to abstain from alcohol during the trial period; 18. Participants with a positive result for any of the following: Hepatitis B virus surface antigen (HBsAg), anti-Hepatitis C virus antibody (Anti-HCV), Treponema pallidum specific antibody, or anti-Human Immunodeficiency Virus antibody (Anti-HIV); 19. Participants with a history of drug abuse and/or use of illicit drugs within 3 months prior to screening; 20. Participants with a positive urine drug screen; 21. Participants with a history of needle phobia, blood phobia, or intolerance to venipuncture for blood sampling; 22. Participants who are pregnant, breastfeeding, or have a positive β-HCG pregnancy test; 23. Participants with specific dietary requirements who cannot comply with the standardized diet and schedule; 24. Participants deemed unsuitable for participation in this study by the investigator for any other reason.
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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 places running it
1 site. The list below names each one and where it is.
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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.
Contacts and locations
Locations
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Huashan Hospital Fudan University
RECRUITINGShanghai, Shanghai Municipality, China
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