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The primary objective of single ascending dose study is to evaluate the safety and tolerability of CY150112 after single oral administration of different doses in healthy Chinese subjects.
Single administration, double-blinded, placebo-controlled (2 subjects in each group will take placebo,8 subjects in each group will take CY150112) and 6 dose groups (0.5mg, 1.5mg, 4.5mg, 10mg, 18mg and 24mg).
This study comprises a screening period (between signing of the informed consent form and Day -1), baseline period (Day -1), treatment period (Days 1-5) and follow-up period(Days 12 or 7 days after discharge ).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 0.5mg CY150112 | Experimental | single oral CY150112 while fasting on day 1. |
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| 1.5mg CY150112 | Experimental | single oral CY150112 while fasting on day 1. |
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| 4.5mg CY150112 | Experimental | single oral CY150112 while fasting on day 1. |
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| 10mg CY150112 | Experimental | single oral CY150112 while fasting on day 1. |
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| 18mg CY150112 | Experimental | single oral CY150112 while fasting on day 1. |
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| 24mg CY150112 | Experimental | single oral CY150112 while fasting on day 1. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 0.5mg CY150112 | Drug | single oral CY150112 while fasting on day 1. |
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| Measure | Description | Time Frame |
|---|---|---|
| Incidence of AEs | Incidence of Adverse Events | pre-dose(within1hour),0.25,0.5,1,1.5,2,2.5,3,4,6,8,12,24,48,96hours post-dose |
| Measure | Description | Time Frame |
|---|---|---|
| Cmax | Maximum (peak) observed drug serum concentration | pre-dose(within1hour),0.25,0.5,1,1.5,2,2.5,3,4,6,8,12,24,48,96hours post-dose |
| AUC0-t | Area under the concentration-time curve from time zero (pre-dose) to the time of the dosing interval |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Hua Fang li, MD | Contact | 021-34773107 | lhlh_5@163.com | |
| Li Yan, Research Doctor | Contact | 021-34773107 | lhlh_5@163.com |
| Name | Affiliation | Role |
|---|---|---|
| Hua Fang li, MD | Shanghai Mental Health Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Shanghai Mental Health Center | Recruiting | Shanghai | Shanghai Municipality | 200030 | China |
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| ID | Term |
|---|---|
| D012559 | Schizophrenia |
| ID | Term |
|---|---|
| D019967 | Schizophrenia Spectrum and Other Psychotic Disorders |
| D001523 | Mental Disorders |
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| 1.5mg CY150112 | Drug | single oral CY150112 while fasting on day 1. |
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| 4.5mg CY150112 | Drug | single oral CY150112 while fasting on day 1. |
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| 10mg CY150112 | Drug | single oral CY150112 while fasting on day 1. |
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| 18mg CY150112 | Drug | single oral CY150112 while fasting on day 1. |
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| 24mg CY150112 | Drug | single oral CY150112 while fasting on day 1. |
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| pre-dose(within1hour),0.25,0.5,1,1.5,2,2.5,3,4,6,8,12,24,48,96hours post-dose |
| AUC0-∞ | Area under the concentration-time curve from time zero (pre-dose) extrapolated to infinite time | pre-dose(within1hour),0.25,0.5,1,1.5,2,2.5,3,4,6,8,12,24,48,96hours post-dose |
| %AUCex | Extrapolation percentage of AUC0-∞ | pre-dose(within1hour),0.25,0.5,1,1.5,2,2.5,3,4,6,8,12,24,48,96hours post-dose |
| Tmax | Time of occurrence of Cmax | pre-dose(within1hour),0.25,0.5,1,1.5,2,2.5,3,4,6,8,12,24,48,96hours post-dose |
| T1/2 | Biological half life correlated with the elimination rate constant (kel) of semi-logarithmic concentration-time curve | pre-dose(within1hour),0.25,0.5,1,1.5,2,2.5,3,4,6,8,12,24,48,96hours post-dose |
| Vd | Apparent volume of distribution | pre-dose(within1hour),0.25,0.5,1,1.5,2,2.5,3,4,6,8,12,24,48,96hours post-dose |
| CL | Clearance | pre-dose(within1hour),0.25,0.5,1,1.5,2,2.5,3,4,6,8,12,24,48,96hours post-dose |
| λz | Elimination rate constant | pre-dose(within1hour),0.25,0.5,1,1.5,2,2.5,3,4,6,8,12,24,48,96hours post-dose |