Could a new pill quiet the mind? early trial puts SYH2056 to the test

NCT ID NCT07771777

What the study statuses mean

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Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting This study
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Aug 18, 2026 · Last updated Sep 09, 2026 · Updated 2 times

Summary

This early-stage trial is testing an experimental oral drug called SYH2056 in healthy adults aged 18 to 55. The main goals are to see how safe and tolerable the drug is, how it moves through the body, and whether taking it with food changes its effects. Participants receive either a single dose of SYH2056 or a placebo, and researchers monitor vital signs, lab tests, and mood-related scales to detect any potential side effects.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
SYH2056 tablets
What this could lead to
If successful, this early trial could pave the way for further studies of SYH2056 as a potential treatment for conditions involving the nervous system or other targets.
What could go wrong
This is a very early, small study focused on safety in healthy people, not on treating a disease. The drug may not prove safe or effective in later trials.

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

Phase 1

The first testing in people. Mainly checks safety and dose, usually in a small group.

Participants

About 72 people

The number the study aims to enrol. It can still change while the study runs.

Expected to start

Aug 2026

An estimate. Start dates often move.

Expected to finish

Mar 2027

An estimate. End dates often move.

Lead sponsor

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

18 to 55 years

Sex

Anyone

Healthy volunteers

Accepted

You do not need to have the condition being studied to take part.

Show 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: Participants must meet all of the following criteria to be enrolled in this study: 1. Age from 18 to 55 years (inclusive). 2. Male or female, with the proportion of either sex being no less than 1/3. 3. Weight ≥45.0 kg (females) or ≥50.0 kg (males), and body mass index (BMI) within the range of 18.0 to 26.0 kg/m2 (inclusive). 4. Results of vital signs, physical examination, 12-lead ECG, laboratory tests, chest X-ray, B-mode ultrasound (liver, gallbladder, spleen, pancreas, kidneys), thyroid function test, etc., are normal or abnormal but not clinically significant as judged by the investigator. 5. The participate and their partner agree to use effective non-hormonal contraceptive methods (e.g., condom, inert intrauterine device, female barrier methods \[cervical cap or diaphragm with spermicide\], vaginal ring, etc.) from signing the ICF until 3 months after the last dose, or have undergone permanent sterilization (e.g., bilateral tubal ligation, vasectomy, etc.). The participate has no plans to donate sperm or eggs from signing the ICF until 3 months after the end of the study. 6. Participates must able to read and understand the written informed consent containing study-related information, fully understand the study content, procedures, and possible adverse reactions, voluntarily participate in the clinical study, sign the written ICF, and comply with the study procedures. Exclusion Criteria: A participate will not be eligible for inclusion in this study if any of the following criteria apply: 1. Participates with history of clinically significant neurological, psychiatric, pulmonary, endocrine, hematological, musculoskeletal, gastrointestinal, cardiovascular, hepatic or renal diseases, or other diseases that might affect the study results or participants' safety as deemed by the investigator or designee. 2. Participates with history of neuropsychiatric disorders, including current or past history of mental illness, current or recent use of psychotropic drugs, or other mental or psychological conditions deemed unsuitable for enrollment by the investigator or designee. 3. Participates with abnormal blood pressure, such as systolic blood pressure ≥140 mmHg or \<90 mmHg; diastolic blood pressure ≥90 mmHg or \<60 mmHg. 4. Participates with abnormal renal function, such as serum creatinine (Scr) \> upper limit of normal (ULN), or estimated glomerular filtration rate (eGFR) \<90 mL/min/1.73m2 or ≥130 mL/min/1.73m2. 5. Participates with history of severe drug or food allergies, or judged by the investigator to be potentially allergic to the investigational drug. 6. Participates who have taken any prescription drugs, over-the-counter drugs, herbal medicines, vitamin/dietary supplements, or health products within 4 weeks before signing the ICF. Or those who are using long-acting oral contraceptives, long-acting contraceptive implants, or hormone-releasing intrauterine devices. 7. Participates with history of diseases which could affect drug absorption, distribution, metabolism, or excretion (e.g., acute or chronic diarrhea or gastritis, gastrectomy, enterectomy, or cholecystectomy, etc., with the exception of appendectomy). 8. Participates who have undergone any surgery within 6 months before signing the ICF, or those who plan to undergo surgery (including cosmetic surgery, dental operation, and oral surgery) during the study. 9. Participates with QTcF interval \>450 ms (males) or \>470 ms (females), or those who have a history of QT interval prolongation. 10. Participates who have experienced blood loss or blood donation exceeding 400 mL within 3 months before signing the ICF, or those who have received a blood transfusion or have used blood products. 11. Regular alcohol consumption, defined as an average weekly alcohol intake \>14 units of alcohol within the 3 months prior to signing the ICF (1 unit = 285 mL of beer, 25 mL of spirits or 150 mL of wine), or positive breath alcohol test, or unable to abstain from alcohol during the study. 12. Participates who smoked ≥ 5 cigarettes per day within 6 months before signing the ICF, or who are unable to abstain from any tobacco products during the study. 13. Participates with habitual excessive consumption of foods, fruits, or beverages containing purines, caffeine, or grapefruit and grapefruit juice, or other foods that may affect drug absorption, distribution, metabolism, or excretion, within 2 weeks before dosing, such as coffee (\>1,100 mL/day), tea (\>2,200 mL/day), cola (\>2,200 mL/day), energy drinks (\>1,100 mL/day) and chocolate (\>510 g/day). 14. Participates who have enrolled in any clinical studies of drug or medical device within 3 months before signing the ICF. 15. Participates with history of drug abuse within 1 year before signing the ICF, or who have a positive drug test as screening. 16. Female participates with a positive pregnancy test at screening or who is lactating. 17. Participates who have positive results in one or more of the following examinations: hepatitis B surface antigen (HBsAg), hepatitis C virus (HCV) antibody, anti-human immunodeficiency virus (HIV) antibody, or anti-Treponema pallidum-specific antibody. 18. Participates with history of needle or blood phobia, or those who have difficulty with venous blood collection or can't tolerate venipuncture for other reasons. 19. Participates with special dietary requirements and cannot accept the standardized diet and schedule. 20. Any other factors that the investigator deems unsuitable for participation in the study.

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