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The study is a randomized, doubled-blinded, placebo-controlled, Phase I trials. The study is divided into two parts. The first part is a single-dose escalated study (SAD,part 1A ) and food effect study (SAD, part 1B ) in healthy subjects. The second part is a multi-dose escalated study (MAD) in healthy subjects.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| SHR2285 Part 1A | Experimental | Participant received one of 7 dose levels of SHR2285 tablet as single-dose oral administration |
|
| Placebo Part 1A | Placebo Comparator | Single ascending doses of placebo orally |
|
| SHR2285 Part 1B | Experimental | Participant received one dose of SHR2285 tablet as single-dose oral administration |
|
| Placebo Part 1B | Placebo Comparator | Single doses of placebo orally |
|
| SHR2285 Part 2 | Experimental | Participant received one of 4 dose levels of SHR2285 tablet as multi-dose oral administration |
|
| Placebo Part 2 | Placebo Comparator | Multiple ascending doses of placebo orally |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| SHR2285 tablet | Drug | single dose or multi-dose |
|
| Measure | Description | Time Frame |
|---|---|---|
| Number of subjects with adverse events and severity of adverse events. | Part 1: Pre-dose to day 7 after single dose administration and Part 2: Pre-dose to day 14after multiple dose administration | |
| Maximum observed serum concentration (Cmax) for Food Effect of SHR2285 on pharmacokinetics parameters in healthy subjects. | Part 1A: Pre-dose to day 7 after single dose administration and Part 1B: Pre-dose to day 7 after single dose administration | |
| Time to maximum observed serum concentration (Tmax) for Food Effect of SHR2285 on pharmacokinetics parameters in healthy subjects. | Part 1A: Pre-dose to day 7 after single dose administration and Part 1B: Pre-dose to day 7 after single dose administration | |
| Time to elimination half-life (T1/2) for Food Effect of SHR2285 on pharmacokinetics parameters in healthy subjects. | Part 1A: Pre-dose to day 7 after single dose administration and Part 1B: Pre-dose to day 7 after single dose administration | |
| Area under the plasma concentration versus time curve (AUC0-last) for Food Effect of SHR2285 on pharmacokinetics parameters in healthy subjects. | Part 1A: Pre-dose to day 7 after single dose administration and Part 1B: Pre-dose to day 7 after single dose administration |
| Measure | Description | Time Frame |
|---|---|---|
| Maximum observed serum concentration (Cmax) for single dose of SHR2285. | Part 1:Pre-dose to day 3 after single dose administration and Part 2:Pre-dose to day 9 after multiple dose administration | |
| Time to maximum observed serum concentration (Tmax) for single dose of SHR2285. |
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Inclusion Criteria:
Exclusion Criteria:
9.3 months prior to screening involved in any drug or medical device clinical studies or within 5 half-life of drugs before screening.
10.Female subjects who did not receive contraception at least 30 days before administration and etc.
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Peking University First Hospital | Beijing | Beijing Municipality | 100034 | China | ||
| The Third Xiangya Hospital of Central South University |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 37326942 | Derived | Xu J, Zhao N, Huang J, Li J, Zhao X, Xiang Q, Yang S, Dong Y, Wang H, Li Y, Yang G, Cui Y. The Safety, Pharmacokinetics, and Pharmacodynamics of SHR2285, an Oral Small Molecule Factor XIa Inhibitor, in Healthy Chinese Volunteers. Clin Drug Investig. 2023 Jun;43(6):435-445. doi: 10.1007/s40261-023-01281-8. Epub 2023 Jun 16. |
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| ID | Term |
|---|---|
| D013927 | Thrombosis |
| ID | Term |
|---|---|
| D016769 | Embolism and Thrombosis |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
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|
| Placebo | Drug | single dose or multi-dose |
|
| Part 1:Pre-dose to day 3 after single dose administration and Part 2:Pre-dose to day 9 after multiple dose administration |
| Time to elimination half-life (T1/2) for single dose of SHR2285. | Part 1:Pre-dose to day 3 after single dose administration and Part 2:Pre-dose to day 9 after multiple dose administration |
| Area under the plasma concentration versus time curve (AUC0-last) for single dose of SHR2285. | Part 1:Pre-dose to day 3 after single dose administration and Part 2:Pre-dose to day 9 after multiple dose administration |
| Steady-state peak concentration (Cmax,ss) for multiple dose of SHR2285. | Pre-dose to day 9 after multiple dose administration |
| Steady state valley concentration (Ctrough,ss) for multiple dose of SHR2285. | Pre-dose to day 9 after multiple dose administration. |
| Accumulation ratio (Racc) for multiple dose of SHR2285. | Pre-dose to day 9 after multiple dose administration |
| Clotting factor XI (FXI) activity . | Part 1:Pre-dose to day 7 after single dose administration and Part 2:Pre-dose to day 14 after multiple dose administration |
| Change of activated partial thromboplastin time (APTT) from baseline. | Part 1:Pre-dose to day 7 after single dose administration and Part 2:Pre-dose to day 14 after multiple dose administration |
| Change of prothrombin time (PT) from baseline. | Part 1:Pre-dose to day 7 after single dose administration and Part 2:Pre-dose to day 14 after multiple dose administration |
| Change of international normalization ratio (INR) from baseline. | Part 1:Pre-dose to day 7 after single dose administration and Part 2:Pre-dose to day 14 after multiple dose administration |
| Changsha |
| Hunan |
| 410006 |
| China |