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Completed

NCT Number: NCT04945616

To Evaluate the Safety and Tolerability of Combined Administration of SHR2285 Tablets With Aspirin, Clopidogrel or Ticagrelor in Healthy Subjects

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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Key information

Age range

18 year–55 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Nanjing Drum Tower Hospital

Nanjing, Jiangsu, 210008, China

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Healthy subjects, aged 18-55 (including boundary);
  • Body mass index (BMI) between 19 to 28 kg/m2 (including boundary), male body weight ≥50 kg and <90 kg , female body weight ≥45kg and <90kg;
  • Participant with no clinically significant findings in vital signs, physical examination, 12-lead ECG ,X-ray and laboratory parameters,etc.
  • Understand the study procedures and methods, voluntary to participate in the study and signed the informed consent.

Exclusion criteria

  • Alanine aminotransferase (ALT) or aspartate aminotransferase (AST) or total bilirubin/direct bilirubin > 1.2 fold ULN during screening/baseline.
  • Serum creatinine> ULN during screening/baseline.
  • Positive faecal occult blood
  • Abnormal coagulation function.
  • A clinical history of coagulation dysfunction; subjects with adverse reaction of antiplatelet drugs or anticoagulant drugs.
  • Subjects with severe head trauma or head surgery within 2 years or surgery within 3 months prior to the screening.
  • Blood donation or blood loss within 1 month≥200 mLor≥400 mL within 3 months before administration.
  • Human immunodeficiency virus antibody, syphilis serological examination, hepatitis b virus surface antigen, hepatitis c virus antibody were positive.
  • 3 months prior to screening involved in any drug or medical device clinical studies. .
  • Female subjects who did not receive contraception at least 30 days before administration and etc.

Treatment and study plan

Aspirin、clopidogrel、placebo or SHR2285

Drug

groupA: Aspirin + clopidogrel + placebo or SHR2285 (dose 1) ;

Aspirin、ticagrelor、placebo or SHR2285

Drug

groupC: Aspirin + ticagrelor + placebo or SHR2285

Primary outcomes

  1. Number of subjects with adverse events and severity of adverse events.

    Time frame: from the first dose to 48hours after the last dose

Secondary outcomes

  1. Cmax

    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.

  2. Tmax

    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.

  3. T1/2

    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.

  4. AUC0-last

    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.

  5. Cmax,ss

    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.

  6. Ctrough,ss

    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.

  7. FXI activity

    Time frame: from Day1 to Day8 after the first dose

    Clotting factor XI (FXI) activity

  8. APTT

    Time frame: from Day1 to Day8 after the first dose

    Change of activated partial thromboplastin time (APTT) from baseline

  9. PT

    Time frame: from Day1 to Day8 after the first dose

    Change of prothrombin time (PT) from baseline

  10. INR

    Time frame: from Day1 to Day8 after the first dose

    Change of international normalization ratio (INR) from baseline

Sponsors and collaborators

Lead sponsor

Jiangsu HengRui Medicine Co., Ltd.

Industry

Registry information

Official study title

Study on the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of SHR2285 Tablets Combined With Aspirin, Clopidogrel or Ticagrelor in Healthy Subjects

Important dates

Study start
2021
Primary completion
2021
Study completion
2022
First posted
Jun 30, 2021
Registry last updated
Jul 1, 2022

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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