A Phase I, Randomized, Double-Blind, Placebo-Controlled, Single-Ascending Dose Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of SHR2285 Tablets in Healthy Subjects

Jiangsu HengRui Medicine Co., Ltd.1 site in 1 country28 target enrollmentFebruary 25, 2019

ConditionsThrombosis

InterventionsSHR2285 Placebo

DrugsSHR2285 Placebo

Overview

Phase: Phase 1
Intervention: SHR2285
Conditions: Thrombosis
Sponsor: Jiangsu HengRui Medicine Co., Ltd.
Enrollment: 28
Locations: 1
Primary Endpoint: Number of subjects with adverse events and serious adverse events
Status: Completed
Last Updated: 4 years ago

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Sites Similar Trials

Overview

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.

Registry

clinicaltrials.gov

Start Date

February 25, 2019

End Date

July 22, 2019

Last Updated

4 years ago

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

Jiangsu HengRui Medicine Co., Ltd.

Responsible Party

Sponsor

Eligibility Criteria

Inclusion Criteria

•males or females, aged 18-45
•subjects with no cardiovascular disease, sitting blood pressure: 90mmHg ≤SBP\<140mmHg and 50mmHg ≤DBP\<90mmHg;
•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
•Participant in general good health. No clinically significant findings in laboratory parameters or clinically significant abnormality on X-ray

Exclusion Criteria

•Alanine aminotransferase (ALT) or aspartate aminotransferase (AST) or total bilirubin \> 1X ULN during screening/baseline;
•Abnormal coagulation function;
•A clinical history of coagulation dysfunction；subjects with adverse reaction of antiplatelet drugs or anticoagulant drugs.
•Subjects with severe trauma or surgery within 3 months prior to the screening；
•Known blood donation within 30 days pre-dose; donating≥400 ml of blood 3 months pre-dose;
•Human immunodeficiency virus antibody (HIV-ab), syphilis serological examination, hepatitis b virus surface antigen (HBsAg), hepatitis c virus antibody (HCV-ab) were positive;
•3 months prior to screening involved in any drug or medical device clinical subjects, or within 5 half-life of drugs before screening;
•Pregnant or Serum β-hCG \> 5mIU/mL at baseline or women who are breastfeeding; etc.

Arms & Interventions

SHR2285

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

Intervention: SHR2285

Placebo

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

Intervention: Placebo

Outcomes

Primary Outcomes

Number of subjects with adverse events and serious adverse events

Time Frame: Pre-dose to 7 days after dose administration

Secondary Outcomes

Mean Residence Time(MRT) of SHR2285(Pre-dose to 2 days after dose administration)
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)
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)
Area under the plasma concentration versus time curve (AUC) 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)
Time to maximum observed serum concentration (Tmax) of SHR2285(Pre-dose to 2 days after dose administration)