Nanjing Drum Tower Hospital
Nanjing, Jiangsu, 210008, China
NCT Number: NCT04945616
The study is a single-center,randomized, doubled-blinded, placebo-controlled, Only for SHR2285 Phase I trial. This study intends to enroll 52 healthy subjects, regardless of gender. The subjects are divided into three groups: A, B, and C, with 16 cases in each of groups A and B, and 20 cases in group C.
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Notify Me18 year–55 year
All sexes
Interventional
Phase 1
Nanjing, Jiangsu, 210008, China
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
groupA: Aspirin + clopidogrel + placebo or SHR2285 (dose 1) ;
groupC: Aspirin + ticagrelor + placebo or SHR2285
Time frame: from the first dose to 48hours after the last dose
Time frame: from Day1 to Day8 after the first dose
Maximum observed serum concentration (Cmax) for acetylsalicylic acid and its active metabolite salicylic acid, clopidogrel, ticagrelor and its active metabolite AR-C124910XX, SHR2285 and its active metabolite steady state after multiple administrations.
Time frame: from Day1 to Day8 after the first dose
Time to maximum observed serum concentration (Tmax) for acetylsalicylic acid and its active metabolite salicylic acid, clopidogrel, ticagrelor and its active metabolite AR-C124910XX, SHR2285 and its active metabolite at steady state after multiple administrations.
Time frame: from Day1 to Day8 after the first dose
Time to elimination half-life (T1/2) for acetylsalicylic acid and its active metabolite salicylic acid, clopidogrel, ticagrelor and its active metabolite AR-C124910XX, SHR2285 and its active metabolite at steady state after multiple administrations.
Time frame: from Day1 to Day8 after the first dose
Area under the plasma concentration versus time curve (AUC0-last) for acetylsalicylic acid and its active metabolite salicylic acid, clopidogrel, ticagrelor and its active metabolite AR-C124910XX, SHR2285 and its active metabolite at steady state after multiple administrations.
Time frame: from Day1 to Day8 after the first dose
Steady-state peak concentration (Cmax,ss) for acetylsalicylic acid and its active metabolite salicylic acid, clopidogrel, ticagrelor and its active metabolite AR-C124910XX, SHR2285 and its active metabolite at steady state after multiple administrations.
Time frame: from Day1 to Day8 after the first dose
Steady state valley concentration (Ctrough,ss) for acetylsalicylic acid and its active metabolite salicylic acid, clopidogrel, ticagrelor and its active metabolite AR-C124910XX, SHR2285 and its active metabolite at steady state after multiple administrations.
Time frame: from Day1 to Day8 after the first dose
Clotting factor XI (FXI) activity
Time frame: from Day1 to Day8 after the first dose
Change of activated partial thromboplastin time (APTT) from baseline
Time frame: from Day1 to Day8 after the first dose
Change of prothrombin time (PT) from baseline
Time frame: from Day1 to Day8 after the first dose
Change of international normalization ratio (INR) from baseline
Jiangsu HengRui Medicine Co., Ltd.
Industry
Study on the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of SHR2285 Tablets Combined With Aspirin, Clopidogrel or Ticagrelor in Healthy Subjects
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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