Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Also known as SYH2056 tablets
SYH2056 · 1 trial · 1 indication
Incidence, severity, seriousness, and relationship of treatment-emergent adverse events (TEAEs) will be assessed by CTCAE V5.0
Changes in systolic and diastolic blood pressure will be assessed during the study（Unit: mmHg）
Changes in pulse rate will be assessed during the study（Unit: beats/min）
Changes in body temperature will be assessed during the study（Unit: °C）
Clinically significant abnormalities identified by physical examination, including general condition, skin and mucous membranes, superficial lymph nodes, head, neck, thyroid, chest (including thorax, lungs, and heart), abdomen, spine/limbs, and nervous system examinations, will be assessed during the study. The results will be presented as the percentage of participants (%) with clinically significant abnormalities
Clinically significant abnormalities identified by hematology tests, including complete blood count parameters, will be assessed during the study. The results will be presented as the percentage of participants(%) with clinically significant abnormalitiesClinically significant abnormalities identified by hematology tests, including complete blood count parameters, will be assessed during the study. The results will be presented as the percentage of participants(%) with clinically significant abnormalities
Clinically significant abnormalities identified by blood biochemistry tests, including liver function, renal function, and metabolic parameters, will be assessed during the study. The results will be presented as the percentage of participants(%) with clinically significant abnormalities
Clinically significant abnormalities identified by coagulation tests, including coagulation parameters, will be assessed during the study. The results will be presented as the percentage of participants(%) with clinically significant abnormalities
Clinically significant abnormalities identified by urinalysis, including urine parameters, will be assessed during the study. The results will be presented as the percentage of participants(%) with clinically significant abnormalities
Changes in 12-lead electrocardiogram parameters, including heart rate, PR interval, QRS interval, QT interval, and QTc interval, will be assessed
Potential effects of SYH2056 on neuropsychiatric status will be assessed by the MOAA/S Score. The MOAA/S score ranges from 0 to 5, with higher scores indicating a higher level of alertness (less sedation) and lower scores indicating a deeper level of sedation.
Potential effects of SYH2056 on neuropsychiatric status will be assessed by the C-SSRS. Suicidal ideation severity is rated from 0 to 5, with higher scores indicating greater severity of suicidal ideation.
| Arm | Type | Description |
|---|---|---|
| Group 1: SYH2056 dose1 | EXPERIMENTAL | Drug: SYH2056 tablets, dose1 on Day1 Other: Placebo matching dose1 on Day1 |
| Group 2: SYH2056 dose2 | EXPERIMENTAL | Drug: SYH2056 tablets, dose2 on Day1 Other: Placebo matching dose2 on Day1 |
| Group 3: SYH2056 dose3 | EXPERIMENTAL | Drug: SYH2056 tablets, dose3 on Day1 Other: Placebo matching dose3 on Day1 |
| Group 4: SYH2056 dose4 | EXPERIMENTAL | Drug: SYH2056 tablets, dose4 on Day1 Other: Placebo matching dose4 on Day1 |
| Group 5: SYH2056 dose5 | EXPERIMENTAL | Drug: SYH2056 tablets, dose5 on Day1 Other: Placebo matching dose5 on Day1 |
| Group 6: SYH2056 dose6 | EXPERIMENTAL | Drug: SYH2056 tablets, dose6 on Day1 Other: Placebo matching dose6 on Day1 |
| Group 7: SYH2056 dose7 | EXPERIMENTAL | Drug: SYH2056 tablets, dose7 on Day1 Other: Placebo matching dose7 on Day1 |
| Group 8: SYH2056 dose8 | EXPERIMENTAL | Drug: SYH2056 tablets with or without food, dose8 on Day1 or on Day5 |
| Group 9: SYH2056 dose9 | EXPERIMENTAL | Drug: SYH2056 tablets with or without food, dose9 on Day1 or on Day5 |
| Name | Type | Description |
|---|---|---|
| SYH2056 tablets | DRUG | SYH2056 tablets, 2mg/tablet or 8mg/tablet, \[WQQ1.1\]taken according to the dosage of arm1 to arm7 on day1 SYH2056 tablets, 8mg/tablet, taken according to the dosage of arm8 and arm9 on day1 or say5 |
| SYH2056 placebo | DRUG | Placebo Comparator, taken matching the dosage of arm1 to arm7 on day1 |
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) wi...