Inclusion Criteria:
1. Voluntarily sign the informed consent form before the start of activities related to
this trial, and be able to fully understand the procedures, methods, contents and
possible adverse reactions of this trial, and be willing to strictly abide by the
clinical trial protocol to complete this trial.
2. Aged 18-45 years (inclusive), healthy male or female;
3. Male weight ≥ 50 kg, female weight ≥ 45 kg, and body mass index (BMI): 19-26 kg/m2
(inclusive), body mass index (BMI) = weight (kg)/(height/100)2 (m2);
4. Physical examination, vital signs, 12-lead electrocardiogram, chest anteroposterior
and lateral radiographs, abdominal ultrasound and laboratory tests during the
screening and baseline periods were normal, or slightly abnormal but clinically
insignificant as determined by the researchers;
5. Female subjects with fertility and male subjects whose partners are women of
childbearing age have taken contraceptive measures within 2 weeks before signing the
informed consent form, and are willing to abstain from sex or agree to contraception
from the signing of the informed consent form until the end of the follow-up period
(non-drug contraception is required during the trial, see Section 13.1.2 for
details), and have no plans to have children or donate sperm/eggs.
Exclusion Criteria:
- - The following diseases or treatment history:
1.
Any serious clinical diseases such as urinary system, circulatory system, endocrine
system, nervous system, digestive system, respiratory system, blood system, immune
system, mental and metabolic disorders in the past or currently, or any other
diseases that the investigators judge may interfere with the results of the trial,
such as intestinal diseases (including irritable bowel syndrome) and urinary tract
infection/stones, etc.;
2. History of malignant tumors (cancers that have been confirmed to have been cured or
relieved for ≥5 years, except for radically resected basal cell or squamous cell
skin cancer, cervical cancer in situ and resected colon polyps);
3. Any conditions or diseases that affect the absorption, metabolism and/or excretion
of the study drug;
4. Severe infection, severe trauma or major surgery within 3 months before the
screening period or baseline period; or plan to undergo surgery during the trial;
5. Have used any drug in the 2 weeks before the screening or baseline period (including
prescription drugs, over-the-counter drugs, Chinese herbal medicines, dietary
supplements, vitamin A and its derivatives, etc., excluding other conventional
vitamins and occasional use of acetaminophen), or still within 5 half-lives of the
drug during the screening or baseline period (whichever is longer); plan to use
non-test drugs during the trial;
6. Participated in clinical trials of any other drugs or medical devices within 3
months before the screening or baseline period or planned to participate in the
study period, or still within 5 half-lives of the drug during the screening or
baseline period (whichever is longer);
Any of the following examinations during screening meet the following criteria:
7. During the screening or baseline period, sitting systolic blood pressure <90 mmHg or
sitting diastolic blood pressure <60 mmHg;
8. During the screening or baseline period, orthostatic hypotension occurs (retest
within 15 minutes to confirm);
9. During the screening or baseline period, abnormal and clinically significant 12-lead
electrocardiogram results, male QTcB>450ms, female QTcB>460ms;
10. During the screening or baseline period, serum creatinine exceeding the upper limit
of normal (ULN);
11. During the screening or baseline period, eGFR < 70 mL/min/1.73m2 (calculated using
the MDRD formula, eGFR (mL/min/1.73m2) = 175×(serum
creatinine/88.4)-1.234×age-0.179×(0.79 female), where serum creatinine units are
μmol/L);
12. During the screening or baseline period, alanine aminotransferase (ALT) or aspartate
aminotransferase (AST) exceeding 1.2 times ULN, or total bilirubin exceeding 1.5
times ULN;
13. During the screening period, any one of the following items is positive: hepatitis B
virus surface antigen (HBsAg), human immunodeficiency virus antibody, syphilis
spirochete antibody or hepatitis C virus antibody;
General situation:
14. Pregnant or lactating women, or positive pregnancy test results during the screening
period/baseline period;
15. History of blood donation or severe blood loss (blood loss ≥400 mL) within 8 weeks
before the screening period or baseline period, or have received blood transfusion
within 4 weeks before the screening period or baseline period; or intend to donate
blood during the trial;
16. Have been vaccinated within 2 weeks before the screening period or baseline period
or plan to be vaccinated during the trial;
17. History of smoking (average daily smoking >5 cigarettes) within 4 weeks before the
screening period or baseline period, or cannot stop using any tobacco products
during the trial;
18. Average daily alcohol intake exceeds 15 g (15 g alcohol is equivalent to 450 mL
beer, 150 mL of wine or about 50mL of low-alcohol liquor), or cannot abstain from
alcohol during the trial; or positive alcohol breath test at baseline;
19. History of drug abuse or drug dependence before the screening period or baseline
period; or positive urine drug test at baseline;
20. Drink excessive amounts of tea, coffee or caffeinated beverages (more than 8 cups
per day, 250 mL per cup) within 6 months before the screening period or baseline
period;
21. Have consumed special foods (such as grapefruit, grapefruit juice or foods/beverages
containing grapefruit juice, chocolate, tobacco, alcohol, caffeinated foods or
beverages) within 48 hours before the baseline period;
22. Have special dietary requirements and cannot follow a unified diet;
23. Have difficulty swallowing, difficulty in venous blood collection, or physical
conditions that cannot withstand intensive blood collection;
24. Other situations in which the researcher determines that the subject is not suitable
for participating in this trial, including but not limited to the following: any
physical or psychological disease or condition that may increase the risk of the
trial, affect the subject's compliance with the protocol, or affect the subject's
completion of the trial.
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