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The Multiple Dose of PK/PD Study of SHR2285 Tablets in Healthy Subjects

Primary Purpose

Thrombus

Status

Completed

Phase

Phase 1

Locations

China

Study Type

Interventional

Intervention

SHR2285 tablet

Placebo

About this trial

This is an interventional treatment trial for Thrombus

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; 50mmHg ≤DBP<90mmHg and 50 ≤ HR <110 beats / min.
body mass index (BMI) between 18 to 28.
Participant in general good health. No clinically significant findings in vital signs, physical examination, 12-lead ECG ,X-ray and laboratory parameters.

Exclusion Criteria:

males or females, aged 18-45.
subjects with no cardiovascular disease, sitting blood pressure: 90mmHg ≤SBP<140mmHg; 50mmHg ≤DBP<90mmHg and 50 ≤ HR <110 beats / min.
body mass index (BMI) between 18 to 28.
Participant in general good health. No clinically significant findings in vital signs, physical examination, 12-lead ECG ,X-ray and laboratory parameters.

Exclusion Criteria:

Alanine aminotransferase (ALT) or aspartate aminotransferase (AST) or total bilirubin/direct bilirubin > 1X ULN during screening/baseline.
Serum creatinine> 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 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 (HIV-ab), syphilis serological examination, hepatitis b virus surface antigen (HBsAg), hepatitis c virus antibody (HCV-ab) were positive.

8.3 months prior to screening involved in any drug or medical device clinical studies or within 5 half-life of drugs before screening.

9.Female subjects who did not receive contraception at least 30 days before administration.

Sites / Locations

Zhejing Provincial People's Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Arm Label

SHR2285

Placebo

Arm Description

Participants received one of 3 dose levels of SHR2285 administered as multiple oral doses.

Participants received one of 3 dose levels of placebo administered as multiple oral doses.

Outcomes

Primary Outcome Measures

Number of subjects with adverse events and serious adverse events.

Secondary Outcome Measures

PK parameter will be evaluated.

Area under the plasma concentration versus time curve (AUC) for single dose of SHR2285.

Maximum observed serum concentration (Cmax) for single dose of SHR2285.

Time to maximum observed serum concentration (Tmax) for single dose of SHR2285.

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

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

Time to elimination half-life (T1/2) for single dose of SHR2285.

Area under the plasma concentration versus time curve (AUC) for multiple dose of SHR2285.

Steady-state peak concentration (Cmax，ss) for multiple dose of SHR2285.

Steady state valley concentration (Ctrough，ss) for multiple dose of SHR2285.

Time to maximum observed serum concentration (Tmax) for multiple dose of SHR2285.

Time to elimination half-life (T1/2) for multiple dose of SHR2285.

Steady-state apparent total clearance of the drug from plasma after oral administration (CLSS/F) for multiple dose of SHR2285.

Steady-state apparent volume of distribution after non-intravenous administration (VSS/F) for multiple dose of SHR2285.

Accumulation ratio (Racc) for multiple dose of SHR2285.

Percentage of fluctuation (PTF%) for multiple dose of SHR2285.

PD parameter will be evaluated.

FXI activity; Change of APTT, PT, INR from baseline.

PD parameter will be evaluated.

FXI activity; Change of APTT, PT, INR from baseline.

Full Information

NCT ID

NCT04229433

First Posted

December 18, 2019

Last Updated

May 21, 2021

Sponsor

Jiangsu HengRui Medicine Co., Ltd.

1. Study Identification

Unique Protocol Identification Number

NCT04229433

Brief Title

The Multiple Dose of PK/PD Study of SHR2285 Tablets in Healthy Subjects

Official Title

A Phase I, Randomized, Single -Blind, Placebo-Controlled, Multiple 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

January 2020

Overall Recruitment Status

Completed

Study Start Date

August 11, 2020 (Actual)

Primary Completion Date

November 8, 2020 (Actual)

Study Completion Date

November 8, 2020 (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

The study is a randomized, single-blind, placebo-controlled, multiple-dose escalation Phase I trials. 2 dose groups were designed, 12 subjects in each dose group.The drug was administered single dose and multiple doses.

6. Conditions and Keywords

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

Thrombus

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 1

Interventional Study Model

Parallel Assignment

Model Description

Multiple dose of PK/PD Study of SHR2285 Tablets in Healthy Subjects

Masking

Participant

Allocation

Randomized

Enrollment

36 (Actual)

8. Arms, Groups, and Interventions

Arm Title

SHR2285

Arm Type

Experimental

Arm Description

Participants received one of 3 dose levels of SHR2285 administered as multiple oral doses.

Arm Title

Placebo

Arm Type

Experimental

Arm Description

Participants received one of 3 dose levels of placebo administered as multiple oral doses.

Intervention Type

Drug

Intervention Name(s)

SHR2285 tablet

Intervention Description

Pharmaceutical form: SHR2285 tablet Route of administration: single dose and multiple doses.

Intervention Type

Drug

Intervention Name(s)

Placebo

Intervention Description

Pharmaceutical form: Placebo tablet Route of administration: single dose and multiple doses.

Primary Outcome Measure Information:

Title

Number of subjects with adverse events and serious adverse events.

Time Frame

Pre-dose to 7 days after multiple dose administration.

Secondary Outcome Measure Information:

Title

PK parameter will be evaluated.

Description

Area under the plasma concentration versus time curve (AUC) for single dose of SHR2285.

Time Frame

Pre-dose to 3 days after single dose administration

Title

Maximum observed serum concentration (Cmax) for single dose of SHR2285.

Time Frame

Pre-dose to 3 days after single dose administration

Title

Time to maximum observed serum concentration (Tmax) for single dose of SHR2285.

Time Frame

Pre-dose to 3 days after single dose administration

Title

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

Time Frame

Pre-dose to 3 days after single dose administration.

Title

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

Time Frame

Pre-dose to 3 days after single dose administration.

Title

Time to elimination half-life (T1/2) for single dose of SHR2285.

Time Frame

Pre-dose to 3 days after single dose administration

Title

Area under the plasma concentration versus time curve (AUC) for multiple dose of SHR2285.

Time Frame

Pre-dose to 2 days after multiple dose administration

Title

Steady-state peak concentration (Cmax，ss) for multiple dose of SHR2285.

Time Frame

Pre-dose to 2 days after multiple dose administration

Title

Steady state valley concentration (Ctrough，ss) for multiple dose of SHR2285.

Time Frame

Pre-dose to 2 days after multiple dose administration

Title

Time to maximum observed serum concentration (Tmax) for multiple dose of SHR2285.

Time Frame

Pre-dose to 2 days after multiple dose administration.

Title

Time to elimination half-life (T1/2) for multiple dose of SHR2285.

Time Frame

Pre-dose to 2 days after multiple dose administration

Title

Steady-state apparent total clearance of the drug from plasma after oral administration (CLSS/F) for multiple dose of SHR2285.

Time Frame

Pre-dose to 2 days after multiple dose administration.

Title

Steady-state apparent volume of distribution after non-intravenous administration (VSS/F) for multiple dose of SHR2285.

Time Frame

Pre-dose to 2 days after multiple dose administration.

Title

Accumulation ratio (Racc) for multiple dose of SHR2285.

Time Frame

Pre-dose to 2 days after multiple dose administration.

Title

Percentage of fluctuation (PTF%) for multiple dose of SHR2285.

Time Frame

Pre-dose to 2 days after multiple dose administration.

Title

PD parameter will be evaluated.

Description

FXI activity; Change of APTT, PT, INR from baseline.

Time Frame

Pre-dose to 3 days after single dose administration.

Title

PD parameter will be evaluated.

Description

FXI activity; Change of APTT, PT, INR from baseline.

Time Frame

Pre-dose to 2 days after multiple dose administration.

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

45 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: males or females, aged 18-45. subjects with no cardiovascular disease, sitting blood pressure: 90mmHg ≤SBP<140mmHg; 50mmHg ≤DBP<90mmHg and 50 ≤ HR <110 beats / min. body mass index (BMI) between 18 to 28. Participant in general good health. No clinically significant findings in vital signs, physical examination, 12-lead ECG ,X-ray and laboratory parameters. Exclusion Criteria: males or females, aged 18-45. subjects with no cardiovascular disease, sitting blood pressure: 90mmHg ≤SBP<140mmHg; 50mmHg ≤DBP<90mmHg and 50 ≤ HR <110 beats / min. body mass index (BMI) between 18 to 28. Participant in general good health. No clinically significant findings in vital signs, physical examination, 12-lead ECG ,X-ray and laboratory parameters. Exclusion Criteria: Alanine aminotransferase (ALT) or aspartate aminotransferase (AST) or total bilirubin/direct bilirubin > 1X ULN during screening/baseline. Serum creatinine> 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 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 (HIV-ab), syphilis serological examination, hepatitis b virus surface antigen (HBsAg), hepatitis c virus antibody (HCV-ab) were positive. 8.3 months prior to screening involved in any drug or medical device clinical studies or within 5 half-life of drugs before screening. 9.Female subjects who did not receive contraception at least 30 days before administration.

Facility Information:

Facility Name

Zhejing Provincial People's Hospital

City

Hangzhou

State/Province

Zhejiang

ZIP/Postal Code

310014

Country

China

12. IPD Sharing Statement

Plan to Share IPD

Undecided

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