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To Assess SHR0302 Oral Solutions and Tablets in Healthy Subjects Clinical Studies of Relative Bioavailability

Primary Purpose

Graft-versus-host Disease

Status
Active
Phase
Phase 1
Locations
China
Study Type
Interventional
Intervention
SHR0302
Sponsored by
Jiangsu HengRui Medicine Co., Ltd.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional basic science trial for Graft-versus-host Disease

Eligibility Criteria

18 Years - 45 Years (Adult)MaleAccepts Healthy Volunteers

Inclusion Criteria: Voluntarily sign the informed consent form before the start of the activities related to the trial, and be able to understand the procedures and methods of the trial, and be willing to strictly abide by the clinical trial protocol to complete the trial; Age 18~45 years old (including both end values, subject to the signing of informed consent), healthy male; Weight ≥ 50 kg, and body mass index (BMI): 19~26 kg/m2 (including both end values); Sign the informed consent form and agree to use non-pharmacological effective contraception within 60 days after the last dose of the test drug. Exclusion Criteria: Those who have a history of tobacco addiction within 3 months before signing the informed consent form (an average of 5 cigarettes smoked > per day), or those who cannot stop using any tobacco products during the study; Those who consumed an average of more than 25 g of alcohol per day (e.g., 750 mL of beer, 250 mL of wine, or 50 mL of liquor) per day in the 3 months prior to signing the informed consent form, or who could not stop using any alcohol-containing products during the study, or who had a positive alcohol breath test at screening; Eating any drink or food containing grapefruit within 7 days before randomization; or eat any beverage or food containing methylxanthines, such as coffee, tea, cola, chocolate, etc., within 2 days before randomization; Allergic constitution, or suspected allergy to any ingredient in SHR0302 drug; Drug abusers, or positive urine drug abuse screening at screening, including: morphine, meth (methamphetamine), ketamine, cocaine, ecstasy (MDMA - Methylenedioxymethamphetamine), marijuana (tetrahydrocannabinol acid); Have any history of clinically serious diseases or diseases or conditions that the investigator believes may affect the test results, including but not limited to circulatory, endocrine, nervous system, digestive system, urinary system or blood, immune, psychiatric and metabolic diseases; Those who have a history of tuberculosis within 6 months before signing the informed consent form; or those with a positive γ-interferon release test (IGRA) within 4 weeks prior to randomization; 12-lead ECG QTcF > 450 ms or other abnormalities judged clinically significant by the investigator in the first 4 weeks of randomization; Vital signs, physical examination, laboratory tests, abdominal ultrasound or chest imaging in the first 4 weeks of randomization suggest that there are abnormalities that are judged to be clinically significant by the investigator; Within 4 weeks before randomization, hepatitis B surface antigen (HBsAg) positive, or anti-hepatitis C virus (HCV) antibody positive, or human immunodeficiency virus (HIV) antibody positive, or syphilis antibody positive; Infections (viral, bacterial, fungal, parasitic infections) that require systemic antimicrobial therapy within 4 weeks of randomization; Use of any prescription drug, over-the-counter drug, Chinese herbal medicine or dietary supplement within 2 weeks prior to randomization; Systemic therapy with inhibitors or inducers of cytochrome P450 3A4 enzyme (CYP3A4) within 4 weeks before randomization (see Annex 2 for details); Those who participated in any drug clinical trial and took the experimental drug within 3 months before randomization (calculated from the start time of the last visit of the last trial) (if the 5 half-lives of the experimental drug exceed 3 months, the time of the 5 half-lives shall prevail); Have received BCG vaccine within 12 months prior to randomization; or vaccination or exposure to other live vaccines or live attenuated vaccines within the first 3 months of randomization; or those who plan to be vaccinated during the trial; Those who have undergone any surgery within the previous 3 months of randomization, or who have not recovered after surgery, or who may have surgery or hospitalization plans during the estimated trial period; Those who donate blood (or lose blood) within 3 months of randomization and donate blood (or blood loss) in an amount ≥ 400 mL, or receive blood transfusion; The investigator judges that the subject has a situation that affects the absorption, distribution, metabolism and excretion of drugs, or has other factors that are not suitable to participate in this study.

Sites / Locations

  • Beijing Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

Treatment group ARM 1

Treatment group ARM 2

Arm Description

SHR0302 tablets, then SHR0302 oral solution

SHR0302 oral solution, then SHR0302 tablets

Outcomes

Primary Outcome Measures

SHR0302 and its main Pk parameter, AUC0-t
SHR0302 and its main Pk parameter, AUC0-inf
SHR0302 and its main Pk parameter, Cmax
Relative bioavailability (F%) value between SHR0302 oral solution and SHR0302 tablet: F% = AUC0-t (oral solution) / AUC0-t (tablet) ×100%

Secondary Outcome Measures

SHR0302 and its main Pk parameter, Tmax (SHR0302 only)
SHR0302 and its main Pk parameter, t1/2 (SHR0302 only)
SHR0302 and its main Pk parameter, CL/F (SHR0302 only)
SHR0302 and its main Pk parameter, Vz/F (SHR0302 only)
Adverse events

Full Information

First Posted
May 4, 2023
Last Updated
June 19, 2023
Sponsor
Jiangsu HengRui Medicine Co., Ltd.
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1. Study Identification

Unique Protocol Identification Number
NCT05856058
Brief Title
To Assess SHR0302 Oral Solutions and Tablets in Healthy Subjects Clinical Studies of Relative Bioavailability
Official Title
To Assess SHR0302 Oral Solutions and Tablets in Healthy Subjects Clinical Studies of Relative Bioavailability (Single-center, Random, Open, Crossed)
Study Type
Interventional

2. Study Status

Record Verification Date
June 2023
Overall Recruitment Status
Active, not recruiting
Study Start Date
May 29, 2023 (Actual)
Primary Completion Date
October 15, 2023 (Anticipated)
Study Completion Date
October 15, 2023 (Anticipated)

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
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

Brief Summary
To assess the relative bioavailability of SHR0302 oral solution and tablet in healthy subjects. To assess the safety and tolerability of a single dose of SHR0302 oral solution and tablet.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Graft-versus-host Disease

7. Study Design

Primary Purpose
Basic Science
Study Phase
Phase 1
Interventional Study Model
Crossover Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
16 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Treatment group ARM 1
Arm Type
Experimental
Arm Description
SHR0302 tablets, then SHR0302 oral solution
Arm Title
Treatment group ARM 2
Arm Type
Experimental
Arm Description
SHR0302 oral solution, then SHR0302 tablets
Intervention Type
Drug
Intervention Name(s)
SHR0302
Intervention Description
SHR0302 oral solution 1 time, SHR0302 tablets 1 time
Primary Outcome Measure Information:
Title
SHR0302 and its main Pk parameter, AUC0-t
Time Frame
day 1 to 8
Title
SHR0302 and its main Pk parameter, AUC0-inf
Time Frame
day 1 to 8
Title
SHR0302 and its main Pk parameter, Cmax
Time Frame
day 1 to 8
Title
Relative bioavailability (F%) value between SHR0302 oral solution and SHR0302 tablet: F% = AUC0-t (oral solution) / AUC0-t (tablet) ×100%
Time Frame
day 1 to 8
Secondary Outcome Measure Information:
Title
SHR0302 and its main Pk parameter, Tmax (SHR0302 only)
Time Frame
day 1 to 8
Title
SHR0302 and its main Pk parameter, t1/2 (SHR0302 only)
Time Frame
day 1 to 8
Title
SHR0302 and its main Pk parameter, CL/F (SHR0302 only)
Time Frame
day 1 to 8
Title
SHR0302 and its main Pk parameter, Vz/F (SHR0302 only)
Time Frame
day 1 to 8
Title
Adverse events
Time Frame
day 1 to 12

10. Eligibility

Sex
Male
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
45 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: Voluntarily sign the informed consent form before the start of the activities related to the trial, and be able to understand the procedures and methods of the trial, and be willing to strictly abide by the clinical trial protocol to complete the trial; Age 18~45 years old (including both end values, subject to the signing of informed consent), healthy male; Weight ≥ 50 kg, and body mass index (BMI): 19~26 kg/m2 (including both end values); Sign the informed consent form and agree to use non-pharmacological effective contraception within 60 days after the last dose of the test drug. Exclusion Criteria: Those who have a history of tobacco addiction within 3 months before signing the informed consent form (an average of 5 cigarettes smoked > per day), or those who cannot stop using any tobacco products during the study; Those who consumed an average of more than 25 g of alcohol per day (e.g., 750 mL of beer, 250 mL of wine, or 50 mL of liquor) per day in the 3 months prior to signing the informed consent form, or who could not stop using any alcohol-containing products during the study, or who had a positive alcohol breath test at screening; Eating any drink or food containing grapefruit within 7 days before randomization; or eat any beverage or food containing methylxanthines, such as coffee, tea, cola, chocolate, etc., within 2 days before randomization; Allergic constitution, or suspected allergy to any ingredient in SHR0302 drug; Drug abusers, or positive urine drug abuse screening at screening, including: morphine, meth (methamphetamine), ketamine, cocaine, ecstasy (MDMA - Methylenedioxymethamphetamine), marijuana (tetrahydrocannabinol acid); Have any history of clinically serious diseases or diseases or conditions that the investigator believes may affect the test results, including but not limited to circulatory, endocrine, nervous system, digestive system, urinary system or blood, immune, psychiatric and metabolic diseases; Those who have a history of tuberculosis within 6 months before signing the informed consent form; or those with a positive γ-interferon release test (IGRA) within 4 weeks prior to randomization; 12-lead ECG QTcF > 450 ms or other abnormalities judged clinically significant by the investigator in the first 4 weeks of randomization; Vital signs, physical examination, laboratory tests, abdominal ultrasound or chest imaging in the first 4 weeks of randomization suggest that there are abnormalities that are judged to be clinically significant by the investigator; Within 4 weeks before randomization, hepatitis B surface antigen (HBsAg) positive, or anti-hepatitis C virus (HCV) antibody positive, or human immunodeficiency virus (HIV) antibody positive, or syphilis antibody positive; Infections (viral, bacterial, fungal, parasitic infections) that require systemic antimicrobial therapy within 4 weeks of randomization; Use of any prescription drug, over-the-counter drug, Chinese herbal medicine or dietary supplement within 2 weeks prior to randomization; Systemic therapy with inhibitors or inducers of cytochrome P450 3A4 enzyme (CYP3A4) within 4 weeks before randomization (see Annex 2 for details); Those who participated in any drug clinical trial and took the experimental drug within 3 months before randomization (calculated from the start time of the last visit of the last trial) (if the 5 half-lives of the experimental drug exceed 3 months, the time of the 5 half-lives shall prevail); Have received BCG vaccine within 12 months prior to randomization; or vaccination or exposure to other live vaccines or live attenuated vaccines within the first 3 months of randomization; or those who plan to be vaccinated during the trial; Those who have undergone any surgery within the previous 3 months of randomization, or who have not recovered after surgery, or who may have surgery or hospitalization plans during the estimated trial period; Those who donate blood (or lose blood) within 3 months of randomization and donate blood (or blood loss) in an amount ≥ 400 mL, or receive blood transfusion; The investigator judges that the subject has a situation that affects the absorption, distribution, metabolism and excretion of drugs, or has other factors that are not suitable to participate in this study.
Facility Information:
Facility Name
Beijing Hospital
City
Beijing
State/Province
Beijing
ZIP/Postal Code
100005
Country
China

12. IPD Sharing Statement

Plan to Share IPD
Undecided

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To Assess SHR0302 Oral Solutions and Tablets in Healthy Subjects Clinical Studies of Relative Bioavailability

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