The PK/PD Study of SHR2285 Tablets in Healthy Subjects

NCT ID: NCT03769831

Last Updated: 2021-05-24

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 28 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-02-25
• Study Completion Date: 2019-07-22

Brief Summary

Thrombosis is a maladaptive process of vascular occlusion and remains a primary cause of cardiovascular morbidity and mortality, The dose-limiting issue with available anticoagulant therapies is bleeding. The primary objective of this study is to assess the safety and tolerability of SHR2285 tablets in healthy subjects. In addition, this study will provide information on Pharmacokinetics and Pharmacodynamics of SHR2285 tablets in healthy subjects.

Conditions

Thrombosis

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: OTHER
• Blinding Strategy: QUADRUPLE

Study Groups

SHR2285

Up to 7 cohorts of healthy subjects will receive a single dose of oral SHR2285 tablet.

Group Type: EXPERIMENTAL

SHR2285

Intervention Type: DRUG

Ascending dose oral adminstration

Placebo

Up to 7 cohorts of healthy subjects will receive a single dose of oral placebo.

Group Type: EXPERIMENTAL

Placebo

Intervention Type: DRUG

Ascending dose oral adminstration

Interventions

SHR2285

Ascending dose oral adminstration

Intervention Type: DRUG

Placebo

Ascending dose oral adminstration

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

1. males or females, aged 18-45

2. subjects with no cardiovascular disease, sitting blood pressure: 90mmHg ≤SBP<140mmHg and 50mmHg ≤DBP<90mmHg;

3. body mass index (BMI) between 18 to 28, and a total body weight: male ≥50.0 kg and <90.0 kg; female ≥45.0 kg and <90.0 kg

4. Participant in general good health. No clinically significant findings in laboratory parameters or clinically significant abnormality on X-ray

Exclusion Criteria

1. Alanine aminotransferase (ALT) or aspartate aminotransferase (AST) or total bilirubin > 1X ULN during screening/baseline;

2. Abnormal coagulation function;

3. A clinical history of coagulation dysfunction；subjects with adverse reaction of antiplatelet drugs or anticoagulant drugs.

4. Subjects with severe trauma or surgery within 3 months prior to the screening；

5. Known blood donation within 30 days pre-dose; donating≥400 ml of blood 3 months pre-dose;

6. Human immunodeficiency virus antibody (HIV-ab), syphilis serological examination, hepatitis b virus surface antigen (HBsAg), hepatitis c virus antibody (HCV-ab) were positive;

7. 3 months prior to screening involved in any drug or medical device clinical subjects, or within 5 half-life of drugs before screening;

8. Pregnant or Serum β-hCG > 5mIU/mL at baseline or women who are breastfeeding; etc.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 45 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Jiangsu HengRui Medicine Co., Ltd.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Peking Union Medical College Hospital

Beijing, Beijing Municipality, China

Countries

China

References

Chen R, Guan X, Hu P, Dong Y, Zhu Y, Zhang T, Zou J, Zhang S. First-In-Human Study to Assess the Safety, Pharmacokinetics, and Pharmacodynamics of SHR2285, a Small-Molecule Factor XIa Inhibitor in Healthy Subjects. Front Pharmacol. 2022 Feb 10;13:821363. doi: 10.3389/fphar.2022.821363. eCollection 2022.

Reference Type: DERIVED

PMID: 35222036 (View on PubMed)

Other Identifiers

SHR2285-101

Identifier Type: -

Identifier Source: org_study_id