Study on the Bioavailability of SHR0302 in Healthy Subjects

October 19, 2021 updated by: Jiangsu HengRui Medicine Co., Ltd.

Study on the Bioavailability of SHR0302 Tablets With 3 Different Formulations in Healthy Subjects (Single Center, Random, Open, 3 Cycles, 6 Sequences)

The study is being conducted to evaluate the safety, and the relative bioavailability of SHR0302 tablets with three different formulations in healthy subjects.

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.
24

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
    • Beijing
      • Beijing, Beijing, China, 100053
        • Xuanwu Hospital Beijing,Capital Medical University

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

Male

Description

Inclusion Criteria:

  1. Volunteer to sign an informed consent form before the start of the relevant activities of this trial, understand the procedures and methods of this trial, and be willing to strictly abide by the clinical trial protocol to complete this trial
  2. 18~45 years old (including both ends, subject to when signing the informed consent form), healthy male
  3. Weight ≥ 50 kg, and body mass index (BMI): 19~26 kg/m2 (including both ends)
  4. Those who have signed the informed consent and have no birth plan within 6 months after the last administration, and agree to take effective contraceptive measures
  5. Able to communicate well with the researcher, and understand and comply with the requirements of this research

Exclusion Criteria:

  1. Suspected of being allergic to the study drug or any ingredient in the study drug, or allergic
  2. Those who have participated in clinical trials of any drugs and medical devices within six months before screening (subject to the signed informed consent form)
  3. Subjects with any systemic inflammatory disease or autoimmune disease
  4. Subjects with a history of recurrent herpes zoster, disseminated herpes zoster or disseminated herpes simplex
  5. Subjects with a history of malignant tumors
  6. Subjects with mental or neurological diseases, unwilling to communicate or have language barriers, unable to fully understand and cooperate
  7. Those who have a history of tuberculosis (TB) within six months before screening, or have clinical or imaging evidence of active or occult TB
  8. Routine blood examination during the screening period: white blood cell count <3.0×109/L and/or neutrophil count <1.5×109/L
  9. Subjects Those with serum creatinine> 1.5 mg/dL (133 μmol/L) at the time of screening
  10. At the time of screening, 12-ECG check QTcF>450 ms or there are other abnormal conditions judged by the investigator to be clinically meaningful
  11. Those who are positive for hepatitis B surface antigen, hepatitis C antibodies, syphilis antibodies, and HIV antibodies
  12. Those who smoked more than 5 cigarettes daily in the 3 months before screening and cannot stop using any Tobacco products
  13. Those who drink regularly in the 6 months before screening, drink more than 14 units of alcohol per week (1 unit = 285 mL of beer, 25 mL of spirits, or 100 mL of wine) and cannot stop using any alcoholic products during the trial; those who have a positive alcohol breath test
  14. People who have a history of drug abuse, drug dependence or a positive urine drug abuse screening before administration, including: morphine, methamphetamine (methamphetamine), ketamine, cocaine, ecstasy (dimethylene) Dioxyamphetamine), cannabis (tetrahydrocannabinolic acid)
  15. Those who have had any surgery within 6 months before screening
  16. Infections that require antimicrobial (virus, bacterial, fungal, and parasitic infections) treatment that occurred within 4 weeks before screening
  17. Donated blood (or blood loss) within 3 months before screening and donated blood (or blood loss) ≥400 mL, or received blood transfusion
  18. Those who have had any acute disease that has been determined by the investigator to be clinically significant within 1 month before screening
  19. Those who have taken any prescription drugs, over-the-counter drugs, Chinese herbal medicines or health products within 14 days before taking the study drugs; those who plan to take non-study drugs or health products during the trial period
  20. The 48 hours before the first dose until the end of the study, the subject refused to stop any methyl yellow Purine beverages or foods, such as coffee, tea, cola, chocolate, etc.; The 7 days before the first dose until the end of the study, the subject refused to stop using any beverages or foods containing grapefruit; there are special dietary requirements that cannot be consistent Eaters
  21. Physical examination, vital signs, laboratory examinations, chest X-ray or chest CT, abdominal ultrasound and other abnormal and clinically meaningful examination results
  22. The researcher believes that there are other subjects who are not suitable for participating in the research

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: Other
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: None (Open Label)

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: group A
Drug: SHR0302
Group A subjects were given oral F1 、F2 and F3 version SHR0302
Drug: SHR0302
Group B subjects were given oral F1 、F3 and F2 version SHR0302
Drug: SHR0302
Group C subjects were given oral F2 、F1 and F3 version SHR0302
Drug: SHR0302
Group D subjects were given oral F2 、F3 and F1 version SHR0302
Drug: SHR0302
Group E subjects were given oral F3 、F1 and F2 version SHR0302
Drug: SHR0302
Group F subjects were given oral F3 、F2 and F1 version SHR0302
Experimental: group B
Drug: SHR0302
Group A subjects were given oral F1 、F2 and F3 version SHR0302
Drug: SHR0302
Group B subjects were given oral F1 、F3 and F2 version SHR0302
Drug: SHR0302
Group C subjects were given oral F2 、F1 and F3 version SHR0302
Drug: SHR0302
Group D subjects were given oral F2 、F3 and F1 version SHR0302
Drug: SHR0302
Group E subjects were given oral F3 、F1 and F2 version SHR0302
Drug: SHR0302
Group F subjects were given oral F3 、F2 and F1 version SHR0302
Experimental: group C
Drug: SHR0302
Group A subjects were given oral F1 、F2 and F3 version SHR0302
Drug: SHR0302
Group B subjects were given oral F1 、F3 and F2 version SHR0302
Drug: SHR0302
Group C subjects were given oral F2 、F1 and F3 version SHR0302
Drug: SHR0302
Group D subjects were given oral F2 、F3 and F1 version SHR0302
Drug: SHR0302
Group E subjects were given oral F3 、F1 and F2 version SHR0302
Drug: SHR0302
Group F subjects were given oral F3 、F2 and F1 version SHR0302
Experimental: group D
Drug: SHR0302
Group A subjects were given oral F1 、F2 and F3 version SHR0302
Drug: SHR0302
Group B subjects were given oral F1 、F3 and F2 version SHR0302
Drug: SHR0302
Group C subjects were given oral F2 、F1 and F3 version SHR0302
Drug: SHR0302
Group D subjects were given oral F2 、F3 and F1 version SHR0302
Drug: SHR0302
Group E subjects were given oral F3 、F1 and F2 version SHR0302
Drug: SHR0302
Group F subjects were given oral F3 、F2 and F1 version SHR0302
Experimental: group E
Drug: SHR0302
Group A subjects were given oral F1 、F2 and F3 version SHR0302
Drug: SHR0302
Group B subjects were given oral F1 、F3 and F2 version SHR0302
Drug: SHR0302
Group C subjects were given oral F2 、F1 and F3 version SHR0302
Drug: SHR0302
Group D subjects were given oral F2 、F3 and F1 version SHR0302
Drug: SHR0302
Group E subjects were given oral F3 、F1 and F2 version SHR0302
Drug: SHR0302
Group F subjects were given oral F3 、F2 and F1 version SHR0302
Experimental: group F
Drug: SHR0302
Group A subjects were given oral F1 、F2 and F3 version SHR0302
Drug: SHR0302
Group B subjects were given oral F1 、F3 and F2 version SHR0302
Drug: SHR0302
Group C subjects were given oral F2 、F1 and F3 version SHR0302
Drug: SHR0302
Group D subjects were given oral F2 、F3 and F1 version SHR0302
Drug: SHR0302
Group E subjects were given oral F3 、F1 and F2 version SHR0302
Drug: SHR0302
Group F subjects were given oral F3 、F2 and F1 version SHR0302

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
Measure Description
Time Frame
The peak plasma concentration (Cmax) of SHR0302.
Time Frame: 0, 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 24, 48 hours post-dose.
Based on the PK concentration data set, calculate the peak plasma concentration of SHR0302 by non-compartmental analysis.
0, 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 24, 48 hours post-dose.
Area Under the Plasma Concentration Versus Time Curve (AUC) of SHR0302.
Time Frame: 0, 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 24, 48 hours post-dose.
Based on the SHR0302 plasma concentration data set, calculate the Area Under the Plasma Concentration Versus Time Curve of SHR0302 by non-compartmental analysis.
0, 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 24, 48 hours post-dose.
The relative bioavailability of SHR0302 tablets with 3 different formulations.
Time Frame: through study completion, an average of 1 month.
The mixed effect model is used to estimate the least square mean difference and 90% confidence interval between different formulations, and then take the antilog to obtain the estimate of the ratio of the least square geometric mean of the corresponding PK parameter and the 90% confidence interval Time.
through study completion, an average of 1 month.

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
The Peak Time (Tmax) of SHR0302.
Time Frame: 0, 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 24, 48 hours post-dose.
Based on the SHR0302 plasma concentration data set, calculate the time to reach peak plasma concentration of SHR0302 by non-compartmental analysis.
0, 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 24, 48 hours post-dose.
The Elimination half-life (T1/2) of SHR0302.
Time Frame: 0, 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 24, 48 hours post-dose.
Based on the SHR0302 plasma concentration data set, calculate the time required for the blood concentration of SHR0302 to drop by half.
0, 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 24, 48 hours post-dose.
The Clearance (CL/F) of SHR0302.
Time Frame: 0, 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 24, 48 hours post-dose.
Based on the SHR0302 plasma concentration data set, calculate the clearance of SHR0302 by non-compartmental analysis.
0, 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 24, 48 hours post-dose.
The apparent volume of distribution (Vz/F) of SHR0302.
Time Frame: 0, 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 24, 48 hours post-dose.
Based on the SHR0302 plasma concentration data set, calculate the apparent volume of distribution of SHR0302 by non-compartmental analysis.
0, 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 24, 48 hours post-dose.
Incidence of adverse events.
Time Frame: through study completion, an average of 1 month
laboratory abnormalities (based on hematology, biochemistry, coagulation function, and urinalysis tests), vital sign measurements (include blood pressure, pulse rate, respiratory rate, and body temperature) and 12-Lead electrocardiogram.
through study completion, an average of 1 month

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.
March 15, 2021

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.
April 13, 2021

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.
April 13, 2021

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).
January 11, 2021

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, 2021

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 15, 2021

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.
October 20, 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.
October 19, 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.
October 1, 2021

More Information

Terms related to this study

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.
  • SHR0302-108

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.

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