Renal insufficiency
Conditions
Interventions
Group 1: Mild to Moderate Renal Insufficiency Group:Subjects should take the supine position under fasting conditions and receive a subcutaneous injection of UBT251. After another person has checked t
Group 2: Severe Renal Insufficiency Group:Subjects should take the supine position under fasting conditions and receive a subcutaneous injection of UBT251. After another person has checked the drug nu
Group 3: Normal Renal Function Group:Subjects should take the supine position under fasting conditions and receive a subcutaneous injection of UBT251. After another person has checked the drug number
Sponsors
The Third Xiangya Hospital of Central South University
Eligibility
Sex/Gender
All
Age
18 Years to 65 Years
Inclusion criteria
Inclusion criteria: 1. Aged between 18 and 65 years old (including both endpoints), regardless of gender. 2. For males, body weight >= 50.0 kg; for females, body weight >= 45.0 kg, and body mass index (BMI) should be between 20.0 and 32.0 kg/m^2 (BMI = body weight (kg) / height^2(m^2)), including both endpoints. 3. Stable renal function status: The results of individual glomerular filtration rate (eGFR calculated by the CKD-EPI formula and then calculated according to the actual body surface area of the subject) measured twice during the screening period and at baseline (D - 1) should be within the same renal function classification (the result of the first measurement can accept the test result obtained outside or inside the hospital within 14 days before screening, and in this case, the test at D - 1 may not be required again) (the two measurements should be at least 3 days apart). 4. Subjects (including their partners) are willing to voluntarily adopt appropriate and effective contraceptive measures from screening until 6 months after the administration of the investigational product (see Appendix 4 for details), and have no plan to donate sperm or eggs within 6 months after the administration of the investigational product. 5. Subjects can communicate well with the investigators, have a full understanding of this study, volunteer to participate, and understand and comply with all the requirements of this study, and sign a written informed consent form. 6. Renal insufficiency group (mild, moderate, or severe renal insufficiency): Subjects are diagnosed with chronic (lasting for more than 3 months) and stable (without acute exacerbation due to deterioration of renal function within 1 month before screening) kidney injury, and their individual glomerular filtration rate during the screening period meets 60 - 89 mL/min (mild renal insufficiency) or 30 - 59 mL/min (moderate renal insufficiency) or 15 - 29 mL/min (severe renal insufficiency). 7. Renal function normal group: The individual glomerular filtration rate should meet the following criteria: >= 90 mL/min and < 130 mL/min.
Exclusion criteria
Exclusion criteria: 1. Known to be allergic to the investigational drug or its pharmaceutical excipients in this trial, or allergic to other GLP-1 receptor agonist drugs, or having a previous history of clinically significant multiple or severe drug allergies, or currently suffering from allergic diseases or having a hypersensitive constitution. 2. Having a history or evidence of any of the following diseases, mainly as follows: (1) Having a personal or family history (within first-degree relatives, i.e., parents, children or siblings) of medullary thyroid carcinoma (MT(3) or multiple endocrine neoplasia type 2 (MEN2); (2) Having a history of malignant tumors within 5 years before screening (except for fully treated cervical carcinoma in situ, basal cell or squamous cell skin cancer, localized prostate cancer after radical surgery, and ductal carcinoma in situ of the breast after radical surgery); (3) Having a history of chronic/acute pancreatitis or pancreatic injury or a history of pancreatic surgery; (4) Having a history of acute cholecystitis, cholelithiasis and severe gallbladder polyps within 6 months before screening, and the investigator assesses that participation in the trial may increase the risk to the subject; (5) Complicated with gastroparesis or other diseases related to gastrointestinal emptying disorders (such as pyloric obstruction, intestinal obstruction, etc.), uncontrolled gastroesophageal reflux disease, or having gastrointestinal diseases that the investigator assesses as increasing the risk after medication (such as severe active ulcers, inflammatory bowel disease, gastroesophageal reflux disease, acute gastroenteritis, symptomatic chronic gastroenteritis, functional gastrointestinal disorders, intestinal tuberculosis, etc.); (6) Having a history of severe hypoglycemic coma or having blood glucose 2 × the upper limit of the reference value range (ULN), or serum total bilirubin 1.5 × ULN; (2) Fasting triglycerides >= 5.6 mmol/L; (3) International normalized ratio (INR) >=1.5 × ULN; (4) Serum calcitonin >= 50 pg/mL (i.e., 50 ng/L); (5) Hemoglobin 110 beats per minute in electrocardiogram examination, or the investigator assesses that the abnormality is clinically significant; (7) Subjects with abnormal blood pressure or poorly controlled blood pressure (defined as blood pressure not within the following range: 90 mmHg <= systolic blood pressure <= 160 mmHg or 60 mmHg <= diastolic blood pressure <=100 mmHg, or there has been an adjustment of antihypertensive drugs within t
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Blood concentration; | — |
Secondary
| Measure | Time frame |
|---|---|
| Immunogenicity indicators;12-lead electrocardiogram indicators ;Adverse Events; | — |
Countries
China
Contacts
Public ContactGuoping Yang
The Third Xiangya Hospital of Central South University
Outcome results
None listed