The PK/PD Study of SHR2285 Tablets in Healthy Subjects

Phase 1

Completed

• Conditions: Thrombosis
• Interventions: Drug: SHR2285; Drug: Placebo

• Registration Number: NCT03769831
• Lead Sponsor: Jiangsu HengRui Medicine Co., Ltd.

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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2018-12
• Study First Submitted: 2018-12-06
• Study First Submitted QC: 2018-12-06
• Study First Posted: 2018-12-10
• Study Start: 2019-02-25
• Primary Completion: 2019-07-22
• Study Completion: 2019-07-22
• Last Update Submitted: 2021-05-20
• Last Update Posted: 2021-05-24

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 28

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
SHR2285	SHR2285	Up to 7 cohorts of healthy subjects will receive a single dose of oral SHR2285 tablet.
Placebo	Placebo	Up to 7 cohorts of healthy subjects will receive a single dose of oral placebo.

Primary Outcome Measures

Name	Time	Method
Number of subjects with adverse events and serious adverse events	Pre-dose to 7 days after dose administration

Secondary Outcome Measures

Name	Time	Method
Change of APTT, PT, INR from baseline.	during Pre and Post-dose
Maximum observed serum concentration (Cmax) of SHR2285	Pre-dose to 2 days after dose administration
Area under the plasma concentration versus time curve (AUC) of SHR2285	Pre-dose to 2 days after dose administration
Time to maximum observed serum concentration (Tmax) of SHR2285	Pre-dose to 2 days after dose administration
Mean Residence Time(MRT) of SHR2285	Pre-dose to 2 days after dose administration
Time to elimination half-life (T1/2) of SHR2285	Pre-dose to 2 days after dose administration
Apparent volume of distribution after non-intravenous administration (V/F) of SHR2285	Pre-dose to 2 days after dose administration
Apparent total clearance of the drug from plasma after oral administration(CL/F) of SHR2285	Pre-dose to 2 days after dose administration

Trial Locations

Locations (1)

Peking Union Medical College Hospital; 🇨🇳 Beijing, Beijing, China