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).
Age from 18 to 55 years (inclusive).
Male or female, with the proportion of either sex being no less than 1/3.
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).
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.
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.
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.
Participates with abnormal blood pressure, such as systolic blood pressure ≥140 mmHg or <90 mmHg; diastolic blood pressure ≥90 mmHg or <60 mmHg.
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.
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Treatment groupsSee each treatment group below.
InnovStone Therapeutics Limited
Lead sponsor
Shanghai Mental Health Center
Collaborator