| Eligibility |
Inclusion Criteria:
1. Voluntarily sign an informed consent form prior to the commencement of activities
related to this trial, be able to understand the procedures and methods of this trial,
and be willing to strictly comply with the clinical trial protocol to complete this
trial;
2. Age 18 to 45 years (inclusive, subject to the signing of informed consent), healthy
male;
3. Body mass = 50 kg and body mass index (BMI): 19 to 26 kg/m2 (both ends included);
4. Be able to communicate well with the investigators and understand and comply with the
requirements of this study.
Exclusion Criteria:
1. Those who have participated in clinical trials of any drug and medical device within
three months before the first administration or who are still in the follow-up period
of a clinical study or 5 half-life periods of the test drug before screening
(whichever is longer), the participant in the clinical trial is defined as: those who
have signed informed consent for clinical trials and have used the test drugs
(including placebo) or experimental medical devices;
2. Those who have chronic or active gastrointestinal diseases such as esophageal
diseases, gastritis, gastric ulcers, enteritis, active gastrointestinal bleeding or
gastrointestinal surgery within three years and the researchers believe that there is
still clinical significance;
3. Those who have a history of respiratory system, cardiovascular system, endocrine
system, urinary system, nervous system, hematology, immunology (including personal or
family history of hereditary immunodeficiency), metabolic abnormalities, etc., and the
researcher believes that there is still clinical significance;
4. Patients with a history of ventricular dysfunction;
5. Have any history of systemic inflammatory diseases, autoimmune diseases, recurrent
herpes zoster, disseminated herpes zoster, and disseminated herpes simplex;
6. Those who have a history of tuberculosis (TB) within half a year before the first
administration;
7. Infections or other acute diseases that need to be treated with antimicrobials (viral,
bacterial, fungal, parasitic infections) within 4 weeks before the first
administration of the drug are judged by the researchers to be unsuitable for
participating in the trial;
8. Allergic to the study drug (SHR0302 tablets and itraconazole capsules) or any
ingredient in the study drug, or have a history of allergy to drugs, food or other
substances;
9. Those who cannot tolerate intravenous puncture or have a history of blood sickness and
needle sickness;
10. Those who have undergone surgery that the researchers judge will affect the
absorption, distribution, metabolism and excretion of the drug within 6 months before
the first administration; or have undergone surgery within 4 weeks before the first
administration; or those who plan to perform surgical operations during the trial
period;
11. Those who have used any drugs (including Chinese herbal medicines, health care
products, etc.) within 14 days before the first administration, or those who plan to
take drugs or health care products that are not experimental in this study during the
trial period;
12. Any drug or food that has been used within 30 days prior to the first administration
is an inhibitor or inducer of the cytochrome P4503A4 enzyme (CYP3A4), as detailed in
Annex 2;
13. those who have received BCG vaccine within 12 months prior to the first dose, or who
have been vaccinated or exposed to other live vaccines or live attenuated vaccines
within 3 months prior to the first dose, or who plan to be vaccinated during the
trial;
14. those who donate blood or lose a large amount of blood (> 400 mL) within 3 months
before the first administration, those who receive blood transfusions or use blood
products, or those who intend to donate blood or blood components during the trial
period or within 3 months after the end of the test;
15. Drug abusers or those who have used soft drugs (such as marijuana) or hard drugs (such
as cocaine, phencyclidine, etc.) within 1 year before the first administration of
drugs;
16. Smokers or smokers with more than 5 cigarettes per day in the 3 months before the
first administration, or who cannot stop using any tobacco-based products during the
trial;
17. Alcoholics or regular drinkers in the 6 months prior to the first administration of
the drug, i.e. those who drink more than 14 units of alcohol per week (1 unit = 360 mL
of beer or 45 mL of spirits or 150 mL of wine with an alcohol content of 45 mL); or
are unwilling to stop drinking alcohol or any alcoholic products during the trial;
18. those who drink excessive amounts of tea, coffee and/or caffeinated beverages (more
than 8 cups, 1 cup = 250 mL) per day, or those who do not agree to stop drinking tea,
coffee and/or caffeinated beverages during the trial period;
19. those who have eaten any beverage or food containing grapefruit within 7 days before
the first administration, or any beverage or food containing methylxanthine, such as
coffee, tea, cola, chocolate, etc., within 48 hours before the first administration;
or do not agree to stop eating the above diet during the trial period;
20. Those who have special requirements for diet and cannot comply with the unified diet;
21. During the test period, strenuous exercise cannot be stopped, or there are other
factors that may affect the absorption, distribution, metabolism, excretion and other
factors of the drug;
22. Volunteers who have a fertility plan, a sperm donation and egg donation plan during
the trial period and 6 months after the end of the trial, or are unwilling to take one
or more non-drug contraceptive measures (such as complete abstinence, condoms,
contraceptive rings, partner sterilization, etc.);
23. Abnormal clinical significance of physical examination, electrocardiogram, vital
signs, color ultrasound of the heart and abdomen, chest orthostatic film, and
laboratory examination (subject to the judgment of the clinician);
24. ECG examination QTc>440 ms;
25. Glomerular filtration rate (eGFR)<90 mL/min/1.73m2(Adopt simplified renal disease
dietary adjustments (MDRDformula calculation,eGFR=186×[serum creatinine value
(mg/dL)]-1.154×[Age (years)]-0.203oreGFR=186×[serum creatinine value
(µmol/L)×0.01131]-1.154×[Age (years)]-0.203);
26. Positive uremic screen test;
27. Positive alcohol breath test;
28. Volunteers may not be able to complete this study for other reasons or have other
reasons that the researchers judge that they are not suitable to participate in the
trial.
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