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

May 21, 2021 updated by: Jiangsu HengRui Medicine Co., Ltd.

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

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
36

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
    • Zhejiang
      • Hangzhou, Zhejiang, China, 310014
        • Zhejing Provincial People's Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years to 45 years (ADULT)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

Inclusion Criteria:

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

Exclusion Criteria:

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

Exclusion Criteria:

  1. Alanine aminotransferase (ALT) or aspartate aminotransferase (AST) or total bilirubin/direct bilirubin > 1X ULN during screening/baseline.
  2. Serum creatinine> 1X ULN during screening/baseline.
  3. Abnormal coagulation function.
  4. A clinical history of coagulation dysfunction; subjects with adverse reaction of antiplatelet drugs or anticoagulant drugs.
  5. Subjects with severe head trauma or head surgery within 2 years or surgery within 3 months prior to the screening.
  6. Blood donation or blood loss within 1 month≥200 mLor≥400 mL within 3 months before administration.
  7. 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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: SINGLE

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
EXPERIMENTAL: SHR2285
Participants received one of 3 dose levels of SHR2285 administered as multiple oral doses.
Drug: SHR2285 tablet
Pharmaceutical form: SHR2285 tablet Route of administration: single dose and multiple doses.
Drug: Placebo
Pharmaceutical form: Placebo tablet Route of administration: single dose and multiple doses.
EXPERIMENTAL: Placebo
Participants received one of 3 dose levels of placebo administered as multiple oral doses.
Drug: SHR2285 tablet
Pharmaceutical form: SHR2285 tablet Route of administration: single dose and multiple doses.
Drug: Placebo
Pharmaceutical form: Placebo tablet Route of administration: single dose and multiple doses.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Time Frame
Number of subjects with adverse events and serious adverse events.
Time Frame: Pre-dose to 7 days after multiple dose administration.
Pre-dose to 7 days after multiple dose administration.

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
PK parameter will be evaluated.
Time Frame: Pre-dose to 3 days after single dose administration
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.
Time Frame: Pre-dose to 3 days after single dose administration
Pre-dose to 3 days after single dose administration
Time to maximum observed serum concentration (Tmax) for single dose of SHR2285.
Time Frame: Pre-dose to 3 days after single dose administration
Pre-dose to 3 days after single dose administration
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.
Pre-dose to 3 days after single dose administration.
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.
Pre-dose to 3 days after single dose administration.
Time to elimination half-life (T1/2) for single dose of SHR2285.
Time Frame: Pre-dose to 3 days after single dose administration
Pre-dose to 3 days after single dose administration
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
Pre-dose to 2 days after multiple dose administration
Steady-state peak concentration (Cmax，ss) for multiple dose of SHR2285.
Time Frame: Pre-dose to 2 days after multiple dose administration
Pre-dose to 2 days after multiple dose administration
Steady state valley concentration (Ctrough，ss) for multiple dose of SHR2285.
Time Frame: Pre-dose to 2 days after multiple dose administration
Pre-dose to 2 days after multiple dose administration
Time to maximum observed serum concentration (Tmax) for multiple dose of SHR2285.
Time Frame: Pre-dose to 2 days after multiple dose administration.
Pre-dose to 2 days after multiple dose administration.
Time to elimination half-life (T1/2) for multiple dose of SHR2285.
Time Frame: Pre-dose to 2 days after multiple dose administration
Pre-dose to 2 days after multiple dose administration
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.
Pre-dose to 2 days after multiple dose administration.
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.
Pre-dose to 2 days after multiple dose administration.
Accumulation ratio (Racc) for multiple dose of SHR2285.
Time Frame: Pre-dose to 2 days after multiple dose administration.
Pre-dose to 2 days after multiple dose administration.
Percentage of fluctuation (PTF%) for multiple dose of SHR2285.
Time Frame: Pre-dose to 2 days after multiple dose administration.
Pre-dose to 2 days after multiple dose administration.
PD parameter will be evaluated.
Time Frame: Pre-dose to 3 days after single dose administration.
FXI activity; Change of APTT, PT, INR from baseline.
Pre-dose to 3 days after single dose administration.
PD parameter will be evaluated.
Time Frame: Pre-dose to 2 days after multiple dose administration.
FXI activity; Change of APTT, PT, INR from baseline.
Pre-dose to 2 days after multiple dose administration.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Jiangsu HengRui Medicine Co., Ltd.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
August 11, 2020

Primary Completion (ACTUAL)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
November 8, 2020

Study Completion (ACTUAL)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
November 8, 2020

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
December 18, 2019

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
January 14, 2020

First Posted (ACTUAL)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
January 18, 2020

Study Record Updates

Last Update Posted (ACTUAL)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
May 25, 2021

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
May 21, 2021

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
January 1, 2020

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • SHR2285-102

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Cookie Settings

We use cookies to ensure that we give you the best experience on our website. For more details carefully read our Privacy and Cookies Policy. ...>>>You can change your preferences or withdraw your consent at any time by deleting the cookies from your website or computer as described in the policy. Please accept it and choose your preferences by ticking the corresponding boxes in the "Manage Settings" section below. Please carefully read our Terms of Service before you proceed with using any part of this website.
«Manage Settings