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The purpose of this study is to evaluate the safety,tolerability,and pharmacokinetics of multiple-accending dose of JS1-1-01。
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| JS1-1-01 | Experimental | JS1-1-01 25mg,50mg,100mg,150mg |
|
| Placebo | Placebo Comparator | placebo 25mg,50mg,100mg,150mg |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| JS1-1-01 | Drug | Oral tables |
| |
| Placebo |
| Measure | Description | Time Frame |
|---|---|---|
| Safety and Tolerability | To evaluate the safety and tolerability of JS1-1-01 in healthy participants by assessing the number, severity and type of adverse events, including changes in laboratory safety tests and electrocardiogram (ECG) | day 11 |
| Measure | Description | Time Frame |
|---|---|---|
| Pharmacokinetics profile after a single dose | Cmax of JS1-1-01 and its major metabolites after a single dose. | day 1 |
| Pharmacokinetics profile after a single dose | Tmax of JS1-1-01 and its major metabolites after a single dose. |
| Measure | Description | Time Frame |
|---|---|---|
| Pharmacodynamics:Concentration of BDNF | Concentration of BDNF(Brain derived neurotrophic factor) | day 9 |
| Pharmacodynamics:Changes in heart rate and blood pressure | Changes in heart rate and blood pressure (systolic/diastolic) compared with baseline |
Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Shanghai Mental Health Center | Shanghai | China |
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| Drug |
Oral tables |
|
| day 1 |
| Pharmacokinetics profile after a single dose | t1/2 of JS1-1-01 and its major metabolites after a single dose. | day 1 |
| Pharmacokinetics profile after a single dose | AUC0-t of JS1-1-01 and its major metabolites after a single dose. | day 1 |
| Pharmacokinetics profile after a single dose | AUC0-∞ of JS1-1-01 and its major metabolites after a single dose. | day 1 |
| Pharmacokinetics profile after a single dose | λz of JS1-1-01 and its major metabolites after a single dose. | day 1 |
| Pharmacokinetics profile after a single dose | Vd/F of JS1-1-01 and its major metabolites after a single dose. | day 1 |
| Pharmacokinetics profile after a single dose | CL/F of JS1-1-01 and its major metabolites after a single dose. | day 1 |
| Pharmacokinetics profile after multiple dosing. | Css_min of JS1-1-01 and its major metabolites after multiple dosing. | day 11 |
| Pharmacokinetics profile after multiple dosing. | Css_max of JS1-1-01 and its major metabolites after multiple dosing. | day 11 |
| Pharmacokinetics profile after multiple dosing. | Css_av of JS1-1-01 and its major metabolites after multiple dosing. | day 11 |
| Pharmacokinetics profile after multiple dosing. | AUC0-tau of JS1-1-01 and its major metabolites after multiple dosing. | day 11 |
| Pharmacokinetics profile after multiple dosing. | AUC0-∞,ss of JS1-1-01 and its major metabolites after multiple dosing. | day 11 |
| Pharmacokinetics profile after multiple dosing. | AUC0-t,ss of JS1-1-01 and its major metabolites after multiple dosing. | day 11 |
| Pharmacokinetics profile after multiple dosing. | Tmax,ss of JS1-1-01 and its major metabolites after multiple dosing. | day 11 |
| Pharmacokinetics profile after multiple dosing. | T1/2,ss of JS1-1-01 and its major metabolites after multiple dosing. | day 11 |
| Pharmacokinetics profile after multiple dosing. | CLss/F of JS1-1-01 and its major metabolites after multiple dosing. | day 11 |
| Pharmacokinetics profile after multiple dosing. | DF of JS1-1-01 and its major metabolites after multiple dosing. | day 11 |
| Pharmacokinetics profile after multiple dosing. | Rac of JS1-1-01 and its major metabolites after multiple dosing. | day 11 |
| day 9 |
| Pharmacodynamics:Incidence of AESI | Incidence of AESI(adverse event of special interest) (nausea, dry mouth, headache, sweating, somnolence) | day 11 |