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Primary Objective:
Secondary objectives:
To explore the safe tolerated dose of YZJ-1139, provide data support for the design of phase II dosing regimen
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| YZJ-1139 Single-dose Group | Experimental | Subjects will be randomized into two groups: the experimental group will receive YZJ-1139; the control group will receive placebo. |
|
| YZJ-1139 multiple-dose Group | Experimental | Subjects will be randomized into two groups;the experimental group will receive YZJ-1139; the control group will receive placebo once a day, 7 days. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| YZJ-1139 | Drug | Single oral dose, 2mg, 5mg, 10mg, 20mg, 40mg, 60mg, 80mg |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs) | From Day 1 to Day 3 post single dose;From Day 1 to Day 14 post multiple dose; |
| Measure | Description | Time Frame |
|---|---|---|
| Cmax of YZJ-1139 | Cmax is defined as the maximum concentration of drug. | From Day 1 to Day 2 post single dose;From Day 1 to Day 8 post multiple dose |
| AUCinf of YZJ-1139 | AUCinf is defined as the concentration of drug extrapolated to infinite time. |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Beijing Ditan Hospital Capital Medical University | Beijing | China |
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| ID | Term |
|---|---|
| D007319 | Sleep Initiation and Maintenance Disorders |
| ID | Term |
|---|---|
| D020919 | Sleep Disorders, Intrinsic |
| D020920 | Dyssomnias |
| D012893 | Sleep Wake Disorders |
| D009422 | Nervous System Diseases |
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Dose escalation
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| YZJ-1139 |
| Drug |
Multiple Dosing ,Each oral dose of 10 mg,20 mg,40 mg or 60 mg |
|
| Placebo | Drug | Placebo administration |
|
| From Day 1 to Day 2 post single dose;From Day 1 to Day 8 post multiple dose |
| AUClast of YZJ-1139 | AUClast is defined as the concentration of drug from time zero to the last observable concentration. | From Day 1 to Day 2 post single dose;From Day 1 to Day 8 post multiple dose |
| AUC0-τ of YZJ-1139 | AUC0-τ is defined as the area under the concentration-time curve over the dosing interval | From Day 1 to Day 8 post multiple dose |
| Css,avg of YZJ-1139 | Css,avg is defined as the average steady state concentration | From Day 1 to Day 8 post multiple dose |
| Css,min of YZJ-1139 | Css,min is defined as the minimum observed concentration at steady | From Day 1 to Day 8 post multiple dose |
| Tmax of YZJ-1139 | Tmax is defined as the time (observed time point) of Cmax | From Day 1 to Day 2 post single dose;From Day 1 to Day 8 post multiple dose |
| t1/2 of YZJ-1139 | From Day 1 to Day 2 post single dose;From Day 1 to Day 8 post multiple dose |
| CL/F of YZJ-1139 | CL/F is defined as the apparent oral clearance following administration of the drug | From Day 1 to Day 2 post single dose;From Day 1 to Day 8 post multiple dose |
| Vz/F of YZJ-1139 | Vz/F is defined as the apparent volume of distribution of the drug | From Day 1 to Day 2 post single dose;From Day 1 to Day 8 post multiple dose |
| Rac of YZJ-1139 | Rac is defined as the accumulation Ratio | From Day 1 to Day 8 post multiple dose |
| D001523 |
| Mental Disorders |