Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Thrombosis is a maladaptive process of vascular occlusion and remains a primary cause of cardiovascular morbidity and mortality, The dose-limiting issue with available anticoagulant therapies is bleeding. The primary objective of this study is to assess the safety and tolerability of SHR2285 tablets in healthy subjects. In addition, this study will provide information on Pharmacokinetics and Pharmacodynamics of SHR2285 tablets in healthy subjects.
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| SHR2285 | Experimental | Up to 7 cohorts of healthy subjects will receive a single dose of oral SHR2285 tablet. |
|
| Placebo | Experimental | Up to 7 cohorts of healthy subjects will receive a single dose of oral placebo. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| SHR2285 | Drug | Ascending dose oral adminstration |
| |
| Placebo |
| Measure | Description | Time Frame |
|---|---|---|
| Number of subjects with adverse events and serious adverse events | Pre-dose to 7 days after dose administration |
| Measure | Description | Time Frame |
|---|---|---|
| Area under the plasma concentration versus time curve (AUC) of SHR2285 | Pre-dose to 2 days after dose administration | |
| Maximum observed serum concentration (Cmax) of SHR2285 | Pre-dose to 2 days after dose administration |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Peking Union Medical College Hospital | Beijing | Beijing Municipality | 100032 | China |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 35222036 | Derived | Chen R, Guan X, Hu P, Dong Y, Zhu Y, Zhang T, Zou J, Zhang S. First-In-Human Study to Assess the Safety, Pharmacokinetics, and Pharmacodynamics of SHR2285, a Small-Molecule Factor XIa Inhibitor in Healthy Subjects. Front Pharmacol. 2022 Feb 10;13:821363. doi: 10.3389/fphar.2022.821363. eCollection 2022. |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| ID | Term |
|---|---|
| D013927 | Thrombosis |
| ID | Term |
|---|---|
| D016769 | Embolism and Thrombosis |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Drug |
Ascending dose oral adminstration |
|
| Time to maximum observed serum concentration (Tmax) of SHR2285 | Pre-dose to 2 days after dose administration |
| Time to elimination half-life (T1/2) of SHR2285 | Pre-dose to 2 days after dose administration |
| Apparent total clearance of the drug from plasma after oral administration(CL/F) of SHR2285 | Pre-dose to 2 days after dose administration |
| Apparent volume of distribution after non-intravenous administration (V/F) of SHR2285 | Pre-dose to 2 days after dose administration |
| Mean Residence Time(MRT) of SHR2285 | Pre-dose to 2 days after dose administration |
| Change of APTT, PT, INR from baseline. | during Pre and Post-dose |