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The Single, Multiple Dose and Food Effect Study of SHR2285 Tablets on Pharmacokinetics and Pharmacodynamics in Healthy Subjects

Primary Purpose

Thrombosis

Status

Completed

Phase

Phase 1

Locations

China

Study Type

Interventional

Intervention

SHR2285 tablet

Placebo

About this trial

This is an interventional treatment trial for Thrombosis

Eligibility Criteria

18 Years - 55 Years (Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

Healthy subjects, aged 18-55 (including boundary);
Body mass index (BMI) between 18 to 28 kg/m2 (including boundary), male body weight ≥50 kg and <90 kg , female body weight ≥45kg and <90kg;
Participant with no clinically significant findings in vital signs, physical examination, 12-lead ECG ,X-ray and laboratory parameters.
Understand the study procedures and methods, voluntary to participate in the study and signed the informed consent.

Exclusion Criteria:

Alanine aminotransferase (ALT) or aspartate aminotransferase (AST) or total bilirubin/direct bilirubin > upper limit of normal (ULN) during screening/baseline.
Serum creatinine> ULN during screening/baseline.
Positive faecal occult blood
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, syphilis serological examination, hepatitis b virus surface antigen, hepatitis c virus antibody were positive.

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

10.Female subjects who did not receive contraception at least 30 days before administration and etc.

Sites / Locations

Peking University First Hospital
The Third Xiangya Hospital of Central South University

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm 5

Arm 6

Arm Type

Experimental

Placebo Comparator

Experimental

Placebo Comparator

Experimental

Placebo Comparator

Arm Label

SHR2285 Part 1A

Placebo Part 1A

SHR2285 Part 1B

Placebo Part 1B

SHR2285 Part 2

Placebo Part 2

Arm Description

Participant received one of 7 dose levels of SHR2285 tablet as single-dose oral administration

Single ascending doses of placebo orally

Participant received one dose of SHR2285 tablet as single-dose oral administration

Single doses of placebo orally

Participant received one of 4 dose levels of SHR2285 tablet as multi-dose oral administration

Multiple ascending doses of placebo orally

Outcomes

Primary Outcome Measures

Number of subjects with adverse events and severity of adverse events.

Maximum observed serum concentration (Cmax) for Food Effect of SHR2285 on pharmacokinetics parameters in healthy subjects.

Time to maximum observed serum concentration (Tmax) for Food Effect of SHR2285 on pharmacokinetics parameters in healthy subjects.

Time to elimination half-life (T1/2) for Food Effect of SHR2285 on pharmacokinetics parameters in healthy subjects.

Area under the plasma concentration versus time curve (AUC0-last) for Food Effect of SHR2285 on pharmacokinetics parameters in healthy subjects.

Secondary Outcome Measures

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

Time to maximum observed serum concentration (Tmax) 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 (AUC0-last) for single 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.

Accumulation ratio (Racc) for multiple dose of SHR2285.

Clotting factor XI (FXI) activity .

Change of activated partial thromboplastin time (APTT) from baseline.

Change of prothrombin time (PT) from baseline.

Change of international normalization ratio (INR) from baseline.

Full Information

NCT ID

NCT04472819

First Posted

July 9, 2020

Last Updated

September 26, 2021

Sponsor

Jiangsu HengRui Medicine Co., Ltd.

1. Study Identification

Unique Protocol Identification Number

NCT04472819

Brief Title

The Single, Multiple Dose and Food Effect Study of SHR2285 Tablets on Pharmacokinetics and Pharmacodynamics in Healthy Subjects

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

September 2021

Overall Recruitment Status

Completed

Study Start Date

August 28, 2020 (Actual)

Primary Completion Date

May 31, 2021 (Actual)

Study Completion Date

May 31, 2021 (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, doubled-blinded, placebo-controlled, Phase I trials. The study is divided into two parts. The first part is a single-dose escalated study (SAD,part 1A ) and food effect study (SAD, part 1B ) in healthy subjects. The second part is a multi-dose escalated study (MAD) 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

Treatment

Study Phase

Phase 1

Interventional Study Model

Parallel Assignment

Masking

ParticipantCare ProviderInvestigator

Allocation

Randomized

Enrollment

104 (Actual)

8. Arms, Groups, and Interventions

Arm Title

SHR2285 Part 1A

Arm Type

Experimental

Arm Description

Participant received one of 7 dose levels of SHR2285 tablet as single-dose oral administration

Arm Title

Placebo Part 1A

Arm Type

Placebo Comparator

Arm Description

Single ascending doses of placebo orally

Arm Title

SHR2285 Part 1B

Arm Type

Experimental

Arm Description

Participant received one dose of SHR2285 tablet as single-dose oral administration

Arm Title

Placebo Part 1B

Arm Type

Placebo Comparator

Arm Description

Single doses of placebo orally

Arm Title

SHR2285 Part 2

Arm Type

Experimental

Arm Description

Participant received one of 4 dose levels of SHR2285 tablet as multi-dose oral administration

Arm Title

Placebo Part 2

Arm Type

Placebo Comparator

Arm Description

Multiple ascending doses of placebo orally

Intervention Type

Drug

Intervention Name(s)

SHR2285 tablet

Intervention Description

single dose or multi-dose

Intervention Type

Drug

Intervention Name(s)

Placebo

Intervention Description

single dose or multi-dose

Primary Outcome Measure Information:

Title

Number of subjects with adverse events and severity of adverse events.

Time Frame

Part 1: Pre-dose to day 7 after single dose administration and Part 2: Pre-dose to day 14after multiple dose administration

Title

Maximum observed serum concentration (Cmax) for Food Effect of SHR2285 on pharmacokinetics parameters in healthy subjects.

Time Frame

Part 1A: Pre-dose to day 7 after single dose administration and Part 1B: Pre-dose to day 7 after single dose administration

Title

Time to maximum observed serum concentration (Tmax) for Food Effect of SHR2285 on pharmacokinetics parameters in healthy subjects.

Time Frame

Part 1A: Pre-dose to day 7 after single dose administration and Part 1B: Pre-dose to day 7 after single dose administration

Title

Time to elimination half-life (T1/2) for Food Effect of SHR2285 on pharmacokinetics parameters in healthy subjects.

Time Frame

Part 1A: Pre-dose to day 7 after single dose administration and Part 1B: Pre-dose to day 7 after single dose administration

Title

Area under the plasma concentration versus time curve (AUC0-last) for Food Effect of SHR2285 on pharmacokinetics parameters in healthy subjects.

Time Frame

Part 1A: Pre-dose to day 7 after single dose administration and Part 1B: Pre-dose to day 7 after single dose administration

Secondary Outcome Measure Information:

Title

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

Time Frame

Part 1:Pre-dose to day 3 after single dose administration and Part 2:Pre-dose to day 9 after multiple dose administration

Title

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

Time Frame

Part 1:Pre-dose to day 3 after single dose administration and Part 2:Pre-dose to day 9 after multiple dose administration

Title

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

Time Frame

Part 1:Pre-dose to day 3 after single dose administration and Part 2:Pre-dose to day 9 after multiple dose administration

Title

Area under the plasma concentration versus time curve (AUC0-last) for single dose of SHR2285.

Time Frame

Part 1:Pre-dose to day 3 after single dose administration and Part 2:Pre-dose to day 9 after multiple dose administration

Title

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

Time Frame

Pre-dose to day 9 after multiple dose administration

Title

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

Time Frame

Pre-dose to day 9 after multiple dose administration.

Title

Accumulation ratio (Racc) for multiple dose of SHR2285.

Time Frame

Pre-dose to day 9 after multiple dose administration

Title

Clotting factor XI (FXI) activity .

Time Frame

Part 1:Pre-dose to day 7 after single dose administration and Part 2:Pre-dose to day 14 after multiple dose administration

Title

Change of activated partial thromboplastin time (APTT) from baseline.

Time Frame

Part 1:Pre-dose to day 7 after single dose administration and Part 2:Pre-dose to day 14 after multiple dose administration

Title

Change of prothrombin time (PT) from baseline.

Time Frame

Part 1:Pre-dose to day 7 after single dose administration and Part 2:Pre-dose to day 14 after multiple dose administration

Title

Change of international normalization ratio (INR) from baseline.

Time Frame

Part 1:Pre-dose to day 7 after single dose administration and Part 2:Pre-dose to day 14 after multiple dose administration

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

55 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: Healthy subjects, aged 18-55 (including boundary); Body mass index (BMI) between 18 to 28 kg/m2 (including boundary), male body weight ≥50 kg and <90 kg , female body weight ≥45kg and <90kg; Participant with no clinically significant findings in vital signs, physical examination, 12-lead ECG ,X-ray and laboratory parameters. Understand the study procedures and methods, voluntary to participate in the study and signed the informed consent. Exclusion Criteria: Alanine aminotransferase (ALT) or aspartate aminotransferase (AST) or total bilirubin/direct bilirubin > upper limit of normal (ULN) during screening/baseline. Serum creatinine> ULN during screening/baseline. Positive faecal occult blood 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, syphilis serological examination, hepatitis b virus surface antigen, hepatitis c virus antibody were positive. 9.3 months prior to screening involved in any drug or medical device clinical studies or within 5 half-life of drugs before screening. 10.Female subjects who did not receive contraception at least 30 days before administration and etc.

Facility Information:

Facility Name

Peking University First Hospital

City

Beijing

State/Province

Beijing

ZIP/Postal Code

100034

Country

China

Facility Name

The Third Xiangya Hospital of Central South University

City

Changsha

State/Province

Hunan

ZIP/Postal Code

410006

Country

China

12. IPD Sharing Statement

Plan to Share IPD

Learn more about this trial

The Single, Multiple Dose and Food Effect Study of SHR2285 Tablets on Pharmacokinetics and Pharmacodynamics in Healthy Subjects

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