| Eligibility |
Inclusion Criteria:
1. Voluntarily sign the informed consent form, communicate well with the investigator and
be able to complete the trial in strict compliance with the protocol;
2. Chinese male subjects judged by the investigator to be healthy;
3. Adults aged 18 to 45 years (including both ends of the spectrum, as at the time of
signing the informed consent form);
4. Weight = 50 kg and a body mass index (BMI) in the range of 19 to 26 kg/m2 (both ends
inclusive).
Exclusion Criteria:
Ancillary examinations :
1. Abnormalities in physical examination, vital signs, routine laboratory tests (complete
blood cell analysis, blood biochemistry, coagulation, urine routine, stool routine +
occult blood), thyroid function, 12-lead ECG, chest CT, abdominal ultrasound (liver,
gallbladder, pancreas, spleen and kidney) and other tests of clinical significance.
2. Resting corrected QT interval (QTcF) >450 ms obtained on a 12-lead ECG.
3. Positive for hepatitis B surface antigen or E antigen, hepatitis C antibody, HIV
antibody and syphilis antibody.
4. Screening for novel coronavirus infection with clinically significant abnormal
C-reactive protein or positive novel coronavirus nucleic acid.
Medication history:
5. Systemic use of any drug that inhibits or induces CYP3A within 30 days prior to the
screening period (e.g., inducers - bosentan, paracetamol, efavirenz, etravirine,
phenobarbital, rifampin, mitotane, phenytoin sodium, carbamazepine, apatamide, etc.;
inhibitors - -erythromycin, clarithromycin, fluconazole, ketoconazole, itraconazole,
posaconazole, voriconazole, ciprofloxacin, diltiazem, fluvoxamine, nelfinavir,
conivaptan, aripitant, crizotinib, imatinib, dronedarone, cyclosporine).
6. Have used any prescription drugs, over-the-counter medicines, herbal remedies or
dietary supplements such as vitamins, calcium supplements within 14 days prior to the
screening period.
Medical and surgery history:
7. History of any clinically significant illness or disease or condition that, in the
opinion of the investigator, may affect the results of the test, including but not
limited to circulatory, respiratory, endocrine, neurological, digestive, urinary or
haematological, immunological, psychiatric and metabolic disorders.
8. History of organic heart disease, heart failure, myocardial infarction, angina
pectoris, unexplained arrhythmias, torsional ventricular tachycardia, ventricular
tachycardia, atrioventricular block, QT prolongation syndrome or symptoms of QT
prolongation syndrome and family history (indicated by genetic evidence or sudden
death of a close relative at a young age due to cardiac causes).
9. Have undergone major surgery within the 6 months prior to the screening period or
where the surgical incision has not fully healed; major surgery includes, but is not
limited to, any surgery with significant risk of bleeding, extended general
anaesthesia, or incisional biopsy or significant traumatic injury.
10. Allergies, such as a known history of allergy to two or more substances; or a
potential allergy to the test drug or its excipients as judged by the investigator.
11. Haemorrhoids or perianal disease with regular/ongoing blood in the stool, irritable
bowel syndrome, inflammatory bowel disease.
Living habits:
12. Habitual constipation or diarrhoea.
13. Alcohol abuse or regular alcohol consumption within the 6 months prior to the
screening period, i.e. more than 14 units of alcohol per week (1 unit = 360 mL of beer
or 45 mL of spirits at 40% alcohol by volume or 150 mL of wine); or an alcohol breath
test result of =20 mg/dL at the screening period.
14. Those who smoked more than 5 cigarettes per day or habitually used nicotine-containing
products in the 3 months prior to the screening period and were unable to quit during
the trial.
15. Substance abuse or use of soft drugs (e.g. cannabis) 3 months prior to the screening
period or hard drugs (e.g. cocaine, amphetamines, phencyclidine, etc.) 1 year prior to
the screening period; or a positive urine drug test during the screening period.
16. Habitual consumption of grapefruit juice or excessive amounts of tea, coffee and/or
caffeinated beverages that cannot be abstained from during the trial.
Others:
17. Workers exposed to prolonged radiological conditions; or who have had significant
radiological exposure (=2 chest/abdominal CTs, or =3 other types of X-ray
examinations) or participated in radiopharmaceutical labelling tests within 1 year
prior to the test.
18. People who have a history of needle sickness or blood sickness, have difficulty
collecting blood or cannot tolerate venipuncture blood collection.
19. Participation in any other clinical trial (including clinical trials such as drugs and
devices) within 3 months prior to the screening period.
20. Those who have been vaccinated within 1 month prior to screening or those who are
scheduled to be vaccinated during the trial period.
21. Those who plan to have children or donate sperm during the trial and within 1 year
after completion of the trial, or who do not agree that subjects and their spouses
should use strict contraception during the trial and within 1 year after completion of
the trial (see Annex 1 for details).
22. Those who have lost or donated up to 400 mL of blood within 3 months prior to the
screening period, or those who have received a blood transfusion within 1 month.
23. Subjects who, in the opinion of the investigator, have any factors that make them
unsuitable for this trial.
|
