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The study is a randomized, Double-Blind, Placebo-Controlled study to evaluate the safety, tolerability and pharmacokinetics, pharmacodynamics of SHR2150.
will consist of 50 healthy subjects, 5 groups. The purpose of this part is to explore the safety, tolerability ,pharmacokinetics and pharmacodynamics of single doses of SHR2150 capsule in healthy subjects.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Treatment group A | Experimental |
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| Treatment group B | Experimental |
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| Treatment group C | Experimental |
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| Treatment group D | Experimental |
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| Treatment group E | Experimental |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| SHR2150;Placebo | Drug | Single dose;SHR2150-dose 1 or Placebo-dose 1 |
| |
| Measure | Description | Time Frame |
|---|---|---|
| The incidence and severity of treatment-related adverse events as assessed by CTCAE v5.0. | 9 DAYS for Group A.B.C.D.E |
| Measure | Description | Time Frame |
|---|---|---|
| Pharmacokinetic parameters of SHR2150, , main metabolite and identified major metabolites in plasma :[AUC0-last] | The area under the concentration-time curve from time zero (pre-dose) to last time. | Up to 96hours |
| Pharmacokinetic parameters of SHR2150, , main metabolite and identified major metabolites in plasma : [AUC0-∞] |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Beijing youan Hospital,Capital medical university | Beijing | Beijing Municipality | 10069 | China |
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| SHR2150;Placebo |
| Drug |
Single dose;SHR2150-dose 2 or Placebo-dose 2 |
|
| SHR2150;Placebo | Drug | Single dose;SHR2150-dose 3 or Placebo-dose 3 |
|
| SHR2150;Placebo | Drug | Single dose;SHR2150-dose 4 or Placebo-dose 4 |
|
| SHR2150;Placebo | Drug | Single dose;SHR2150-dose 5 or Placebo-dose 5 |
|
The area under the concentration-time curve from time zero (pre-dose) extrapolated to infinite time. |
| Up to 96hours |
| Pharmacokinetic parameters of SHR2150, , main metabolite and identified major metabolites in plasma :[t1/2] | Terminal Half-life | Up to 96hours |
| Pharmacokinetic parameters of SHR2150, , main metabolite and identified major metabolites in plasma: [Tmax] | Time to Maximum Observed Concentration | Up to 96hours |
| Pharmacokinetic parameters of SHR2150, , main metabolite and identified major metabolites in plasma : [Cmax] | Maximum Observed Plasma Concentration | Up to 96hours |
| Pharmacokinetic parameters of SHR2150, , main metabolite and identified major metabolites in plasma : [CL/F] | Apparent clearance | Up to 96hours |
| Pharmacokinetic parameters of SHR2150, , main metabolite and identified major metabolites in plasma : [Vz/F] | Apparent volume of distribution | Up to 96hours |
| Pharmacokinetic parameters of SHR2150, , main metabolite and identified major metabolites in plasma : [MRT] | Mean retention time | Up to 96hours |
| Pharmacodynamics: Changes in Cytokines in Serum: interferon γ-inducible protein-10 | Up to 48hhours |
| Pharmacodynamics: Changes in Cytokines in Serum: Interferon-α | Up to 48hours |