| Eligibility |
Inclusion Criteria:
- Healthy adult male;
- Age: 18-45 years old (including boundary value);
- Body weight: Body mass index (BMI) is between 19 and 26 kg/m2 (including the boundary
value), and the weight of the subject is not less than 50 kg;
- Sign the informed consent form voluntarily;
- The subjects were able to communicate well with the researchers and complete the trial
according to the protocol.
Exclusion Criteria:
- Those with abnormal and clinically significant results from comprehensive physical
examination, vital signs, routine laboratory examination (blood routine examination,
blood biochemistry, blood coagulation function, urine routine examination, stool
routine examination, glycosylated hemoglobin, lipase, amylase), thyroid function, 12
lead ECG, chest CT, abdominal B ultrasound (liver, gallbladder, pancreas, spleen and
kidney), etc;
- Abnormal ophthalmic examination (slit lamp, intraocular pressure and fundus
photography) with clinical significance;
- Hepatitis B surface antigen or E antigen, anti HCV IgG, HIV Ag/Ab and Treponema
pallidum antibody positive;
- Cytomegalovirus (CMV) antibody positive;
- Novel coronavirus nucleic acid positive;
- Any drugs that inhibit or induce liver drug metabolizing enzymes were used within 30
days before the screening period (see Appendix 1 for details);
- Have used any prescription drugs, over-the-counter drugs, Chinese herbal medicine or
food supplements, such as vitamins and calcium supplements, within 14 days before the
screening period;
- Any serious clinical disease history or any disease or circumstance that the
researcher thinks may affect the test results, including but not limited to the
history of circulatory system, respiratory system, endocrine system, nervous system,
digestive system, urinary system or blood, immune, mental and metabolic diseases;
- People with any disease that increases the risk of elevated blood sugar, such as those
with a history of primary diabetes, steroid induced diabetes or other secondary
diabetes, and those with acute or chronic pancreatitis;
- People who have a history of organic heart disease, heart failure, myocardial
infarction, angina pectoris, unexplained arrhythmia, history of torsade, ventricular
tachycardia, atrioventricular block, history of prolonged QT syndrome, or symptoms of
prolonged QT syndrome and family history (certified by genetics or sudden death of a
close relative due to cardiac causes when young);
- History of interstitial lung disease, severe impairment of lung function, severe
pulmonary fibrosis, radiation pneumonitis, drug-induced lung disease, and chest CT
findings during screening period suggest evidence of active pulmonary inflammation;
- Major surgery or incomplete healing of surgical incision within 6 months before the
screening period; Major surgery includes, but is not limited to, any surgery with
significant bleeding risk, extended general anesthesia period, or open biopsy or
obvious traumatic injury;
- Allergic constitution, such as known history of allergy to two or more substances; Or
the investigator may be allergic to the test drug or its excipients;
- Hemorrhoids or perianal diseases, irritable bowel syndrome, inflammatory bowel disease
with regular/ongoing blood in the stool;
- People with multiple factors affecting oral administration and drug absorption (such
as inability to swallow, gastrointestinal resection, ulcerative colitis,
symptomatic/inflammatory bowel disease, intestinal obstruction, etc.); habits and
customs:
- Habitual constipation or diarrhea;
- Excessive drinking or regular drinking within 6 months before the screening period,
that is, drinking more than 14 units of alcohol every week (1 unit=360 mL beer or 45
mL liquor with 40% alcohol or 150 mL wine); Or the results of alcohol breath test
during screening period = 20 mg/dl;
- Those who smoke more than 5 cigarettes a day or habitually use nicotine containing
products in the first 3 months of the screening period and cannot quit during the
trial period;
- Abuse of drugs or use of soft drugs (such as marijuana) 3 months before the screening
period or use of hard drugs (such as cocaine, amphetamines, and phencyclidine) 1 year
before the screening period; Or positive urine drug test during screening period;
- Those who habitually drink grapefruit juice or excessive tea, coffee and/or
caffeinated drinks, and cannot give up during the test; other:
- Workers who need to be exposed to radioactive conditions for a long time; Or those who
have significant radiation exposure (= 2 chest/abdomen CT, or = 3 other kinds of X-ray
examinations) or participated in the radiopharmaceutical labeling test within 1 year
before the test;
- Those who have a history of needle fainting and blood fainting, and who have
difficulty in blood collection or can not tolerate venous puncture blood collection;
- Participated in any other clinical trials (including drug and device clinical trials)
within 3 months before the screening period;
- Those who have been vaccinated within one month before screening or who plan to be
vaccinated during the trial period;
- hose who have fertility or sperm donation plans during the trial and within one year
after the completion of the trial, or those who do not agree that the subject and
his/her spouse should take strict contraceptive measures during the trial and within
one year after the completion of the trial (see Appendix 3 for details);
- People who have lost blood or donated blood up to 400 mL within 3 months before the
screening period, or received blood transfusion within 1 month;
- Subjects who are considered by the researcher to have any factors unsuitable for this
experiment.
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