| Eligibility |
Inclusion Criteria:
1. Age range from 18 to 65 years old (including both ends, subject to signing the
informed consent form), both male and female;
2. The subject's body weight is = 50 kg, and the body mass index (BMI) is within the
range of 19.0~32.0 kg/m2 (including both ends);
3. From the signing of the informed consent form until 6 months after the last
administration, the subject (including partner) has no family planning and is willing
to use the high-efficiency contraceptive measures specified in the plan;
4. Before the experiment, voluntarily sign an informed consent form and have a thorough
understanding of the experiment content, process, and potential adverse reactions.
5. For Moderately renal insufficiency subjects, 30 mL/min = GFR<60, and the renal
function status is stable. Did not use drugs for treating renal insufficiency or was
determined by the researcher to be stable in taking drugs for treating renal
insufficiency for more than 4 weeks.
6. For Healthy subjects,90 mL/min < GFR;there was no history of chronic kidney disease
during screening. Weight, age, and gender should meet the matching requirements for
subjects with moderate renal insufficiency.
Exclusion Criteria:
1. During screening period, glutamate alanine aminotransferase (AST) = 2 × Upper limit of
normal range (ULN); Glutamate aspartate aminotransferase (ALT) = 2 × ULN; Total
bilirubin (TBIL) = 1.5 × ULN;
2. Abnormal and clinically significant 12 lead electrocardiogram (ECG), or ECG QTcF>450
ms (corrected according to Fridericia's formula);
3. Hepatitis B surface antigen is positive, hepatitis C antibody is positive, Treponema
pallidum antibody is positive, HIV antibody is positive;
4. Have a history of life-threatening diseases within 5 years (excluding basal cell skin
cancer or squamous cell skin cancer);
5. Previous history of medullary thyroid cancer, multiple endocrine neoplasia type 2 or
family history, previous history of pancreatitis or symptomatic gallbladder disease;
6. Previous clinical history of gastric emptying abnormalities (such as gastric outlet
obstruction), severe chronic gastrointestinal diseases (such as inflammatory bowel
disease and active ulcers);
7. Other clinically significant diseases (including but not limited to gastrointestinal,
renal, hepatic, neurological, hematological, endocrine, tumor, lung, immune,
psychiatric, or cardiovascular diseases) found within the first 6 months of screening;
8. Have undergone gastrointestinal surgery that can cause malabsorption before screening,
or have taken drugs that have a direct impact on gastrointestinal peristalsis for a
long time;
9. Have used drugs that may affect glucose metabolism within the first month of screening
(such as systemic steroids and non-selective drugs) ß Receptor blockers, monoamine
oxidase inhibitors);
10. Have used glucagon like peptide peptide-1 receptor agonists within the first 3 months
of screening;
11. Individuals with severe allergic diseases or known or suspected allergies or allergies
to any component of the study drug (including multiple drug and food allergies);
12. Discontinuation of glucagon like peptide-1 receptor agonist therapy due to
safety/tolerance reasons or lack of efficacy in the past;
13. Have received clinical trial treatment of any drug or medical device within the first
3 months or 5 half-lives (whichever is longer) before screening, or plan to
participate in clinical trials of other drugs or medical devices during the trial
period;
14. Screening for individuals who have consumed more than 14 units of alcohol per week
within the first 6 months or who have taken alcoholic products 48 hours before
administration; Or positive for alcohol breath test;
15. Smoking more than 5 cigarettes per day within the first 3 months of screening or using
any tobacco products 48 hours before administration;
16. Exercise vigorously within 48 hours before administration;
17. Those who have a history of drug abuse within the past five years or have used drugs
in the three months prior to the trial; Or positive for urine drug screening;
18. Donate = 200 mL of blood within one month before screening; Or select trauma or
surgical major surgeries who have donated blood = 400 mL or lost blood = 400 mL within
the first 3 months;
19. Inability to tolerate venous puncture blood collection or needle dizziness;
20. Have special dietary requirements and cannot follow a unified diet;
21. Patients with fasting blood glucose>11.1 mmol/L;
22. Subjects who the researchers believe have other factors that are not suitable for
participating in this experiment.
23. For Moderately renal insufficiency subjects: Have a history of kidney
transplantation;Urinary incontinence or oliguria (such as<400 mL/d);Within 14 days
prior to administration, medication other than those used to treat renal insufficiency
and other accompanying diseases has been taken that affects the experiment; After
examination and inquiry, according to the judgment of the researcher, there are
serious accompanying diseases that pose a serious threat to the patient's safety or
affect the patient's ability to complete this study.
24. For Healthy subjects: Have taken any medication that affects the experiment within 14
days before administration; Those who have clinical significance in judging
abnormalities through comprehensive physical examination, vital signs, laboratory
examination, X-ray chest X-ray, abdominal ultrasound examination, etc.
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