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

NCT04945616 | Completed Phase 1

• 1 other identifier: SHR2285-106
• Study Type: interventional
• Target: 52
• Locations: 1 country
• Sites: 1

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.

Conditions

Thrombosis

Outcome Measures

Primary Outcomes (1)

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

  from the first dose to 48hours after the last dose

Secondary Outcomes (10)

• Cmax

  from Day1 to Day8 after the first dose

• Tmax

  from Day1 to Day8 after the first dose

• T1/2

  from Day1 to Day8 after the first dose

• AUC0-last

  from Day1 to Day8 after the first dose

• Cmax，ss

  from Day1 to Day8 after the first dose

Study Arms (3)

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

EXPERIMENTAL

Drug: Aspirin、clopidogrel、placebo or SHR2285

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

EXPERIMENTAL

Drug: Aspirin、clopidogrel、placebo or SHR2285

group C： Aspirin + Ticagrelor + placebo or SHR2285

EXPERIMENTAL

Drug: Aspirin、ticagrelor、placebo or SHR2285

Interventions

Aspirin、clopidogrel、placebo or SHR2285 DRUG

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

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

Aspirin、ticagrelor、placebo or SHR2285 DRUG

groupC： Aspirin + ticagrelor + placebo or SHR2285

group C： Aspirin + Ticagrelor + placebo or SHR2285

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.
• 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.

Sponsors & Collaborators

• Jiangsu HengRui Medicine Co., Ltd.: lead

Study Sites (1)

Nanjing Drum Tower Hospital

Nanjing, Jiangsu, 210008, China

Location

MeSH Terms

Conditions

Thrombosis

Condition Hierarchy (Ancestors)

Embolism and Thrombosis; Vascular Diseases; Cardiovascular Diseases

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 1, 2021
• First Posted: June 30, 2021
• Study Start: July 13, 2021
• Primary Completion: October 19, 2021
• Study Completion: June 15, 2022
• Last Updated: July 1, 2022

Record last verified: 2022-06

Locations

CN (1)