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

Thrombosis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04945616
• Other study ID #: SHR2285-106
• Status: Completed
• Phase: Phase 1
• Start date: July 13, 2021
• Est. completion date: June 15, 2022

Study information

• Verified date: June 2022
• Source: Jiangsu HengRui Medicine Co., Ltd.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 52
• Est. completion date: June 15, 2022
• Est. primary completion date: October 19, 2021
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 55 Years

Eligibility

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.

Related Conditions & MeSH terms

• Thrombosis

Intervention

Drug:
• Aspirin?clopidogrel?placebo or SHR2285
groupA: Aspirin + clopidogrel + placebo or SHR2285 (dose 1) ;
• Aspirin?clopidogrel?placebo or SHR2285
groupB: Aspirin + clopidogrel + placebo or SHR2285 (dose 2)
• Aspirin?ticagrelor?placebo or SHR2285
groupC: Aspirin + ticagrelor + placebo or SHR2285

Locations

Country	Name	City	State
China	Nanjing Drum Tower Hospital	Nanjing	Jiangsu

Sponsors (1)

Lead Sponsor	Collaborator
Jiangsu HengRui Medicine Co., Ltd.

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of subjects with adverse events and severity of adverse events.		from the first dose to 48hours after the last dose
Secondary	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.	from Day1 to Day8 after the first dose
Secondary	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.	from Day1 to Day8 after the first dose
Secondary	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.	from Day1 to Day8 after the first dose
Secondary	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.	from Day1 to Day8 after the first dose
Secondary	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.	from Day1 to Day8 after the first dose
Secondary	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.	from Day1 to Day8 after the first dose
Secondary	FXI activity	Clotting factor XI (FXI) activity	from Day1 to Day8 after the first dose
Secondary	APTT	Change of activated partial thromboplastin time (APTT) from baseline	from Day1 to Day8 after the first dose
Secondary	PT	Change of prothrombin time (PT) from baseline	from Day1 to Day8 after the first dose
Secondary	INR	Change of international normalization ratio (INR) from baseline	from Day1 to Day8 after the first dose