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

Primary Purpose

Thrombosis

Status
Completed
Phase
Phase 1
Locations
China
Study Type
Interventional
Intervention
Aspirin、clopidogrel、placebo or SHR2285
Aspirin、clopidogrel、placebo or SHR2285
Aspirin、ticagrelor、placebo or SHR2285
Sponsored by
Jiangsu HengRui Medicine Co., Ltd.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Thrombosis

Eligibility Criteria

18 Years - 55 Years (Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  1. Healthy subjects, aged 18-55 (including boundary);
  2. 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;
  3. Participant with no clinically significant findings in vital signs, physical examination, 12-lead ECG ,X-ray and laboratory parameters,etc.
  4. Understand the study procedures and methods, voluntary to participate in the study and signed the informed consent.

Exclusion Criteria:

  1. Alanine aminotransferase (ALT) or aspartate aminotransferase (AST) or total bilirubin/direct bilirubin > 1.2 fold ULN during screening/baseline.
  2. Serum creatinine> ULN during screening/baseline.
  3. Positive faecal occult blood
  4. Abnormal coagulation function.
  5. A clinical history of coagulation dysfunction; subjects with adverse reaction of antiplatelet drugs or anticoagulant drugs.
  6. Subjects with severe head trauma or head surgery within 2 years or surgery within 3 months prior to the screening.
  7. Blood donation or blood loss within 1 month≥200 mLor≥400 mL within 3 months before administration.
  8. Human immunodeficiency virus antibody, syphilis serological examination, hepatitis b virus surface antigen, hepatitis c virus antibody were positive.
  9. 3 months prior to screening involved in any drug or medical device clinical studies. .
  10. Female subjects who did not receive contraception at least 30 days before administration and etc.

Sites / Locations

  • Nanjing Drum Tower Hospital

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Experimental

Experimental

Arm Label

group A: Aspirin + Clopidogrel + placebo or SHR2285 (dose 1)

group B :Aspirin + Clopidogrel + placebo or SHR2285 (dose 2)

group C: Aspirin + Ticagrelor + placebo or SHR2285

Arm Description

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Cmax
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.
Tmax
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.
T1/2
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.
AUC0-last
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.
Cmax,ss
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.
Ctrough,ss
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.
FXI activity
Clotting factor XI (FXI) activity
APTT
Change of activated partial thromboplastin time (APTT) from baseline
PT
Change of prothrombin time (PT) from baseline
INR
Change of international normalization ratio (INR) from baseline

Full Information

First Posted
June 1, 2021
Last Updated
June 30, 2022
Sponsor
Jiangsu HengRui Medicine Co., Ltd.
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1. Study Identification

Unique Protocol Identification Number
NCT04945616
Brief Title
To Evaluate the Safety and Tolerability of Combined Administration of SHR2285 Tablets With Aspirin, Clopidogrel or Ticagrelor in Healthy Subjects
Official Title
Study on the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of SHR2285 Tablets Combined With Aspirin, Clopidogrel or Ticagrelor in Healthy Subjects
Study Type
Interventional

2. Study Status

Record Verification Date
June 2022
Overall Recruitment Status
Completed
Study Start Date
July 13, 2021 (Actual)
Primary Completion Date
October 19, 2021 (Actual)
Study Completion Date
June 15, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Jiangsu HengRui Medicine Co., Ltd.

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

Brief Summary
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Thrombosis

7. Study Design

Primary Purpose
Other
Study Phase
Phase 1
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigator
Allocation
Randomized
Enrollment
52 (Actual)

8. Arms, Groups, and Interventions

Arm Title
group A: Aspirin + Clopidogrel + placebo or SHR2285 (dose 1)
Arm Type
Experimental
Arm Title
group B :Aspirin + Clopidogrel + placebo or SHR2285 (dose 2)
Arm Type
Experimental
Arm Title
group C: Aspirin + Ticagrelor + placebo or SHR2285
Arm Type
Experimental
Intervention Type
Drug
Intervention Name(s)
Aspirin、clopidogrel、placebo or SHR2285
Intervention Description
groupA: Aspirin + clopidogrel + placebo or SHR2285 (dose 1) ;
Intervention Type
Drug
Intervention Name(s)
Aspirin、clopidogrel、placebo or SHR2285
Intervention Description
groupB: Aspirin + clopidogrel + placebo or SHR2285 (dose 2)
Intervention Type
Drug
Intervention Name(s)
Aspirin、ticagrelor、placebo or SHR2285
Intervention Description
groupC: Aspirin + ticagrelor + placebo or SHR2285
Primary Outcome Measure Information:
Title
Number of subjects with adverse events and severity of adverse events.
Time Frame
from the first dose to 48hours after the last dose
Secondary Outcome Measure Information:
Title
Cmax
Description
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
Title
Tmax
Description
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
Title
T1/2
Description
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
Title
AUC0-last
Description
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
Title
Cmax,ss
Description
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
Title
Ctrough,ss
Description
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
Title
FXI activity
Description
Clotting factor XI (FXI) activity
Time Frame
from Day1 to Day8 after the first dose
Title
APTT
Description
Change of activated partial thromboplastin time (APTT) from baseline
Time Frame
from Day1 to Day8 after the first dose
Title
PT
Description
Change of prothrombin time (PT) from baseline
Time Frame
from Day1 to Day8 after the first dose
Title
INR
Description
Change of international normalization ratio (INR) from baseline
Time Frame
from Day1 to Day8 after the first dose

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
55 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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.
Facility Information:
Facility Name
Nanjing Drum Tower Hospital
City
Nanjing
State/Province
Jiangsu
ZIP/Postal Code
210008
Country
China

12. IPD Sharing Statement

Plan to Share IPD
Undecided

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

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