Clinical trial NCT04712838: Study on the Bioavailability of SHR0302 in Healthy Subjects
Official title: Study on the Bioavailability of SHR0302 Tablets With 3 Different Formulations in Healthy Subjects (Single Center, Random, Open, 3 Cycles, 6 Sequences)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Healthy Subjects
Lead sponsor: Jiangsu HengRui Medicine Co., Ltd.
Sponsor class: INDUSTRY
First posted: 2021-01-15
Enrollment: 24
Sex: MALE
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Intervention model description: The relative bioavailability of SHR0302 tablets with three different formulations
Primary purpose: OTHER

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


Eligibility criteria: 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

Primary outcomes:
measure: The peak plasma concentration (Cmax) of SHR0302.
timeFrame: 0, 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 24, 48 hours post-dose.
measure: Area Under the Plasma Concentration Versus Time Curve (AUC) of SHR0302.
timeFrame: 0, 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 24, 48 hours post-dose.
measure: The relative bioavailability of SHR0302 tablets with 3 different formulations.
timeFrame: through study completion, an average of 1 month.
Secondary outcomes:
measure: The Peak Time (Tmax) of SHR0302.
timeFrame: 0, 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 24, 48 hours post-dose.
measure: The Elimination half-life (T1/2) of SHR0302.
timeFrame: 0, 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 24, 48 hours post-dose.
measure: The Clearance (CL/F) of SHR0302.
timeFrame: 0, 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 24, 48 hours post-dose.
measure: The apparent volume of distribution (Vz/F) of SHR0302.
timeFrame: 0, 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 24, 48 hours post-dose.
measure: Incidence of adverse events.
timeFrame: through study completion, an average of 1 month
Other outcomes:
Locations:
city: Beijing
country: China
facility: Xuanwu Hospital Beijing,Capital Medical University
state: Beijing
Study officials:
References: