A Single Ascending Dose Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and the Effect of Food of SYH2056 in Healthy Subjects

A Randomized, Double-Blind, Placebo-controlled, Single Ascending Dose Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Food-Effect of SYH2056 Tablets in Healthy Subjects

This is a single-center, randomized, double-blind, placebo-controlled study to evaluate the safety, tolerability, PK characteristics, and food effect of single ascending oral doses of SYH2056 tablets in healthy participants. The study is planned to have two Parts: Part 1 [the single ascending dose (SAD) study] and Part 2 (the food effect study).

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.