The Multiple Dose of PK/PD Study of SHR2285 Tablets in He... | NCT04229433

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

NCT04229433

Sponsor

Jiangsu HengRui Medicine Co., Ltd.

Status

Completed

Last Update Posted

May 25, 2021Actual

Enrollment

36Actual

Phase

Phase 1

Conditions

Thrombus

Interventions

SHR2285 tablet
Placebo

Countries

China

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jan 2020

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Aug 11, 2020Actual

Primary Completion Date

Nov 8, 2020Actual

Completion Date

Nov 8, 2020Actual

First Submitted Date

Dec 18, 2019

First Submission Date that Met QC Criteria

Jan 14, 2020

First Posted Date

Jan 18, 2020Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

May 21, 2021

Last Update Posted Date

May 25, 2021Actual

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 1

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

36Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
SHR2285	Experimental	Participants received one of 3 dose levels of SHR2285 administered as multiple oral doses.	Drug: SHR2285 tablet Drug: Placebo
Placebo	Experimental	Participants received one of 3 dose levels of placebo administered as multiple oral doses.	Drug: SHR2285 tablet Drug: Placebo

Interventions

Name	Type	Description	Arm Group Labels	Other Names
SHR2285 tablet	Drug	Pharmaceutical form: SHR2285 tablet Route of administration: single dose and multiple doses.	Placebo SHR2285

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Number of subjects with adverse events and serious adverse events.		Pre-dose to 7 days after multiple dose administration.

Secondary Outcomes

Measure	Description	Time Frame
PK parameter will be evaluated.	Area under the plasma concentration versus time curve (AUC) for single dose of SHR2285.	Pre-dose to 3 days after single dose administration
Maximum observed serum concentration (Cmax) for single dose of SHR2285.

Other Outcomes

Not provided

Eligibility Module

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.

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

45 Years

Standard Ages

Adult

Study Population

Not provided

Sampling Method

Not provided

ID	Term
D016769	Embolism and Thrombosis
D014652	Vascular Diseases
D002318	Cardiovascular Diseases