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CompletedNCT05856058Updated Dec 8, 2023

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

A Phase 1 interventional study of SHR0302 in Graft-versus-host Disease, sponsored by Jiangsu HengRui Medicine Co., Ltd.. Completed at 1 site in China. Open to male participants aged 18 Years to 45 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2023-12-08.

Sponsored by Jiangsu HengRui Medicine Co., Ltd. · Phase 1, Interventional, and Basic science

Phase
Phase 1
Study type
Interventional
Enrollment
16
Allocation
Randomized
Ages
18 Years to 45 Years
Sex
Male
01

Study 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.

02

Conditions studied

  • Graft-versus-host Disease

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03

In context

Graft vs Host Disease

806 studies on the registry are indexed under Graft vs Host Disease; 138 are open to participants now.

This study's enrollment of 16 is below the median of 35 across 637 interventional studies indexed under Graft vs Host Disease.

Browse Graft vs Host Disease studies →

Lead sponsor

Jiangsu HengRui Medicine Co., Ltd. is the lead sponsor of 559 studies on the registry; 85 are open to participants now.

Of its 9 completed or terminated interventional studies of FDA-regulated products, 1 (11%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 45 Years
Sexes eligible
Male
Accepts healthy volunteers
Yes

Inclusion criteria

  1. 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;
  2. Age 18\~45 years old (including both end values, subject to the signing of informed consent), healthy male;
  3. Weight ≥ 50 kg, and body mass index (BMI): 19\~26 kg/m2 (including both end values);
  4. 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

Exclusion Criteria:

  1. 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;
  2. 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;
  3. 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;
  4. Allergic constitution, or suspected allergy to any ingredient in SHR0302 drug;
  5. Drug abusers, or positive urine drug abuse screening at screening, including: morphine, meth (methamphetamine), ketamine, cocaine, ecstasy (MDMA - Methylenedioxymethamphetamine), marijuana (tetrahydrocannabinol acid);
  6. 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;
  7. 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;
  8. 12-lead ECG QTcF > 450 ms or other abnormalities judged clinically significant by the investigator in the first 4 weeks of randomization;
  9. 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;
  10. 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;
  11. Infections (viral, bacterial, fungal, parasitic infections) that require systemic antimicrobial therapy within 4 weeks of randomization;
  12. Use of any prescription drug, over-the-counter drug, Chinese herbal medicine or dietary supplement within 2 weeks prior to randomization;
  13. Systemic therapy with inhibitors or inducers of cytochrome P450 3A4 enzyme (CYP3A4) within 4 weeks before randomization (see Annex 2 for details);
  14. 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);
  15. 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;
  16. 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;
  17. 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;
  18. 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.
05

Study design

Phase
Phase 1
Primary purpose
Basic science
Allocation
Randomized
Intervention model
Crossover assignment
Masking
None (open label)
Enrollment
16 participants (actual)

Study arms

  • Experimental
    Treatment group ARM 1

    SHR0302 tablets, then SHR0302 oral solution

    Drug: SHR0302

  • Experimental
    Treatment group ARM 2

    SHR0302 oral solution, then SHR0302 tablets

    Drug: SHR0302

Interventions

  • DrugSHR0302

    SHR0302 oral solution 1 time, SHR0302 tablets 1 time

06

What researchers measure

Primary outcomes

  1. SHR0302 and its main Pk parameter, AUC0-t

    Time frame: day 1 to 8

  2. SHR0302 and its main Pk parameter, AUC0-inf

    Time frame: day 1 to 8

  3. SHR0302 and its main Pk parameter, Cmax

    Time frame: day 1 to 8

  4. 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 outcomes

  1. SHR0302 and its main Pk parameter, Tmax (SHR0302 only)

    Time frame: day 1 to 8

  2. SHR0302 and its main Pk parameter, t1/2 (SHR0302 only)

    Time frame: day 1 to 8

  3. SHR0302 and its main Pk parameter, CL/F (SHR0302 only)

    Time frame: day 1 to 8

  4. SHR0302 and its main Pk parameter, Vz/F (SHR0302 only)

    Time frame: day 1 to 8

  5. Adverse events

    Time frame: day 1 to 12

07

Study locations

1 site
  • Beijing Hospital
    Beijing, Beijing 100005, China
08

References and documents

Individual participant data

Plan to share: Undecided

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Dec 8, 2023, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT05856058
Lead sponsor
Jiangsu HengRui Medicine Co., Ltd.
Responsible party
Sponsor
First posted
May 12, 2023
Start date
May 29, 2023
Primary completion
Jul 3, 2023
Completion
Oct 9, 2023
Last update
Dec 8, 2023

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Dec 2023. You cannot join it, but the record below documents what was studied.

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