Clinical trial NCT04945616: 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
Overall status: COMPLETED
Phase: PHASE1
Conditions: Thrombosis
Lead sponsor: Jiangsu HengRui Medicine Co., Ltd.
Sponsor class: INDUSTRY
First posted: 2021-06-30
Enrollment: 52
Sex: ALL
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

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.


Eligibility criteria: 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.

Primary outcomes:
measure: Number of subjects with adverse events and severity of adverse events.
timeFrame: from the first dose to 48hours after the last dose
Secondary outcomes:
measure: Cmax
timeFrame: from Day1 to Day8 after the first dose
measure: Tmax
timeFrame: from Day1 to Day8 after the first dose
measure: T1/2
timeFrame: from Day1 to Day8 after the first dose
measure: AUC0-last
timeFrame: from Day1 to Day8 after the first dose
measure: Cmax，ss
timeFrame: from Day1 to Day8 after the first dose
measure: Ctrough，ss
timeFrame: from Day1 to Day8 after the first dose
measure: FXI activity
timeFrame: from Day1 to Day8 after the first dose
measure: APTT
timeFrame: from Day1 to Day8 after the first dose
measure: PT
timeFrame: from Day1 to Day8 after the first dose
measure: INR
timeFrame: from Day1 to Day8 after the first dose
Other outcomes:
Locations:
city: Nanjing
country: China
facility: Nanjing Drum Tower Hospital
state: Jiangsu
Study officials:
References: