Back to results

The PK/PD Study of SHR2285 Tablets in Healthy Subjects

Primary Purpose

Thrombosis

Status

Completed

Phase

Phase 1

Locations

China

Study Type

Interventional

Intervention

SHR2285

Placebo

About this trial

This is an interventional other trial for Thrombosis

Eligibility Criteria

18 Years - 45 Years (Adult)All SexesAccepts Healthy Volunteers

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.

Sites / Locations

Peking Union Medical College Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Arm Label

SHR2285

Placebo

Arm Description

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

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

Outcomes

Primary Outcome Measures

Number of subjects with adverse events and serious adverse events

Secondary Outcome Measures

Area under the plasma concentration versus time curve (AUC) of SHR2285

Maximum observed serum concentration (Cmax) of SHR2285

Time to maximum observed serum concentration (Tmax) of SHR2285

Time to elimination half-life (T1/2) of SHR2285

Apparent total clearance of the drug from plasma after oral administration(CL/F) of SHR2285

Apparent volume of distribution after non-intravenous administration (V/F) of SHR2285

Mean Residence Time(MRT) of SHR2285

Change of APTT, PT, INR from baseline.

Full Information

NCT ID

NCT03769831

First Posted

December 6, 2018

Last Updated

May 20, 2021

Sponsor

Jiangsu HengRui Medicine Co., Ltd.

1. Study Identification

Unique Protocol Identification Number

NCT03769831

Brief Title

The PK/PD Study of SHR2285 Tablets in Healthy Subjects

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

December 2018

Overall Recruitment Status

Completed

Study Start Date

February 25, 2019 (Actual)

Primary Completion Date

July 22, 2019 (Actual)

Study Completion Date

July 22, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Jiangsu HengRui Medicine Co., Ltd.

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Thrombosis

7. Study Design

Primary Purpose

Other

Study Phase

Phase 1

Interventional Study Model

Parallel Assignment

Masking

ParticipantCare ProviderInvestigatorOutcomes Assessor

Allocation

Randomized

Enrollment

28 (Actual)

8. Arms, Groups, and Interventions

Arm Title

SHR2285

Arm Type

Experimental

Arm Description

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

Arm Title

Placebo

Arm Type

Experimental

Arm Description

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

Intervention Type

Drug

Intervention Name(s)

SHR2285

Intervention Description

Ascending dose oral adminstration

Intervention Type

Drug

Intervention Name(s)

Placebo

Intervention Description

Ascending dose oral adminstration

Primary Outcome Measure Information:

Title

Number of subjects with adverse events and serious adverse events

Time Frame

Pre-dose to 7 days after dose administration

Secondary Outcome Measure Information:

Title

Area under the plasma concentration versus time curve (AUC) of SHR2285

Time Frame