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This is a phase 1 open-label study
This is a phase 1 open-label study. The objective of this study is to evaluate the safety, tolerability, pharmacokinetics and pharmacodynamics of oral administered SHR2285 in healthy subjects
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Low dose of SHR2285 | Experimental | The subjects will receive a single dose of SHR2285 (cohort 1). |
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| Medium dose of SHR2285 | Experimental | The subjects will receive a single dose of SHR2285 (cohort 2). |
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| High dose of SHR2285 | Experimental | The subjects will receive a single dose of SHR2285 (cohort 3). |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| SHR2285 | Drug | SHR2285 is a selective inhibition of human FXIa small molecule compound. |
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| Measure | Description | Time Frame |
|---|---|---|
| Adverse events | Incidence and severity of adverse events | Start of Treatment to end of study (approximately 7 days) |
| Measure | Description | Time Frame |
|---|---|---|
| Pharmacokinetics-AUC0-last | Area under the concentration-time curve from time 0 to last time point after SHR2285 administration | Start of Treatment to outpatient (approximately 3 days) |
| Pharmacokinetics-AUC0-inf |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Dr Jasmine Daisy Williams | Study Principal Investigator | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Linear Clinical research | Perth | Western Australia | 6009 | Australia |
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Three different cohorts can enroll healthy Caucasian participants; males and females in each cohort separately.
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Area under the concentration-time curve from time 0 to infinity after SHR2285 administration
| Start of Treatment to outpatient (approximately 3 days) |
| Pharmacokinetics-Tmax | Time to Cmax of SHR2285 and its metabolite SHR164471 | Up to 3 days |
| Pharmacokinetics-Cmax | Maximum observed concentration of SHR2285 and its metabolite SHR164471 | Up to 3 days |
| Pharmacokinetics-CL/F | Apparent clearance of SHR2285 and its metabolite SHR164471 | Up to 3 days |
| Pharmacokinetics-Vz/F | Apparent volume of distribution during terminal phase of SHR2285 and its metabolite SHR164471 | Up to 3 days |
| Pharmacokinetics-t1/2 | Terminal elimination half-life of SHR2285 and its metabolite SHR164471 | Up to 3 days |
| Coagulation factor XI (FXI) activity | Coagulation factor XI (FXI) activity | Up to 3 days |
| Percentage change of coagulation factor XI (FXI) activity thromboplastin time (APTT) and fold change from baseline | Percentage change of coagulation factor XI (FXI) activity | Up to 3 days |
| Activated partial thromboplastin time | Activated partial thromboplastin time | Up to 3 days |
| Fold change of activated partial thromboplastin time from baseline | Fold change of activated partial thromboplastin time from baseline | Up to 3 days |
| Prothrombin time | Prothrombin time | Up to 3 days |
| Fold change of prothrombin time from baseline | Fold change of prothrombin time from baseline | Up to 3 days |
| International normalized ratio | International normalized ratio | Up to 3 days |
| Fold change of international normalized ratio from baseline | Fold change of international normalized ratio from baseline | Up to 3 days |