diabetic nephropathy
Conditions
Interventions
Queue 1: Normal renal function:This cohort evaluated the pharmacokinetic profile of XW003 Injection as a single dose in 6-10 subjects with normal renal function.
Queue 2: Mild renal insufficiency:This cohort evaluated the pharmacokinetic profile of XW003 Injection administered as a single dose in 6-10 subjects with mild renal insufficiency.
Queue 3: moderate renal insufficiency:This cohort evaluated the pharmacokinetic profile of XW003 Injection administered as a single dose in 6-10 subjects with moderate renal insufficiency.
Sponsors
Clinical Trial Center of Third Xiangya Hospital of Central South University
Eligibility
Sex/Gender
All
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: Subjects must meet all of the following criteria to be enrolled: 1) The subject is able to communicate well with the investigator, has a full understanding of the purpose of the study, the process, and possible adverse effects, understands and complies with the requirements set forth in this study, and voluntarily signs an informed consent form. 2) Subjects have no plans to have children or to donate sperm or eggs during the study period and for 3 months after the administration of the study drug, and voluntarily use highly effective and medically approved contraceptive measures. 3) Males and non-pregnant, non-lactating females (not less than 2 of each sex in each cohort), aged 18-75 years at the time of informed consent (including cut-offs). 4) Subjects in the renal insufficiency group: a) Subjects weighed no less than 50.0 kg and had a body mass index (BMI) between 20 and 30 kg/m2 (including cut-off), and mild renal insufficiency was matched (±10%) to the weight of subjects in the moderate renal insufficiency cohort; b) Subjects diagnosed with chronic (>3 months), stable (no acute exacerbation due to deterioration of renal function within 4 weeks prior to Screening) renal insufficiency, with a Screening Individual GFR of 60-89 mL/min (including cut-offs) (Mild Renal Insufficiency, Cohort 2) or 30-59 mL/min (including cut-offs) (Moderate Renal Insufficiency, Cohort 3). 3). Renal function was evaluated by converting eGFR calculated by the CKD-EPI formula (Appendix I) into individual GFR. 5) Subjects in the normal renal function group: a) Subjects weighing no less than 50.0 kg with a body mass index (BMI) between 20 and 30 kg/m2 (inclusive), matched to the weight of subjects in the Renal Insufficiency Cohort (±10%); b) Individual GFR =90 mL/min during the screening period. renal function is evaluated by converting eGFR calculated according to the CKD-EPI formula (Appendix I) to individual GFR.
Exclusion criteria
Exclusion criteria: Subjects meeting any of the following exclusion criteria must be excluded: 1) Persons with a history of specific allergies (asthma, urticaria, eczema, allergy to GLP-1 analogues or excipients, etc.), or allergies (e.g., allergy to two or more medications, foods such as milk and pollen). (2) Previous personal or family history of medullary thyroid carcinoma (MTC) or multiple endocrine neoplasia type 2 (MEN2). 3) Prior diagnosis of malignant tumour (except cured basal cell carcinoma of the skin or carcinoma in situ of the cervix) within the last 5 years. (4) Subjects with severe gastrointestinal diseases (e.g., active ulcer, gastroparesis, pyloric obstruction, inflammatory bowel disease, etc.) or gastrointestinal surgeries within 6 months prior to the screening date, or subjects with chronic gastrointestinal diseases who have used long-term medications directly affecting gastrointestinal motility, and who are assessed to be unsuitable for participation in the clinical trial by the investigator. (5) Subjects who have had or are suspected to have had hypoglycaemic episodes within 6 months prior to screening. (6) Subjects who have had a major illness or surgery within 4 weeks prior to screening, or who are scheduled to undergo surgery or other reasons for hospitalisation during the study period. 7) Previous history of acute or chronic pancreatitis. 8) History of acute hepatitis or chronic liver disease within 6 months prior to screening. (9) Fever within 1 week prior to dosing. (10) Clinician's judgement that the following conditions are met during the screening period by comprehensive physical examination, electrocardiogram, vital signs examination, abdominal ultrasound, and laboratory tests (routine blood, coagulation function, blood biochemistry, thyroid function, calcitonin, and routine urinalysis): a) Triglycerides = 500 mg/dL (5.65 mmol/L) at screening; b) Calcitonin = 50 ng/L (pg/mL) at screening; c) Serum amylase and/or lipase = 1.5 upper limit of normal (ULN) at screening; d) Alanine aminotransferase (ALT) or aspartate aminotransferase (AST) > 2.5 ULN at the time of screening; or or serum total bilirubin (TBIL) >2 ULN at screening; e) Other abnormalities judged by the clinician to be clinically significant. (11) Positive for any of hepatitis B surface antigen, hepatitis C virus antibody, anti-human immunodeficiency virus antibody or syphilis spirochete antibody. (12) Regular alcohol consumption in the 6 months prior to screening, i.e., consumption of more than 2 units of alcohol per week (1 unit = 360 mL of beer at 5% alcohol, or 45 mL of spirits at 40% alcohol, or 150 mL of wine at 12% alcohol), and/or disagreement with the cessation of alcohol intake in the 48 hours prior to and during hospitalisation, and/or positive admission to an alcohol breath test. Positive breath test for alcohol. (13) Smoking an average of more than 10 cigarettes per day in the 3 months prior to screening and/or do not agree to refrain from the use of any tobacco products during the hospitalisation period. (14) Have a history of prior drug use, a history of substance abuse within 6 months prior to screening, or a positive substance abuse screen. (15) History of needle and blood sickness, difficulty in collecting blood, or inability to tolerate venipuncture for blood collection. (16) Participation in any medical device clinical trial or drug clinical trial within 3 months prior to screening, and use of medical devices and/or drugs used in the trial. (17) Ha
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| adverse event;adverse event;physical examination;electrocardiogram (ECG);Cmax;AUC0-t;AUC0-8; | — |
Secondary
| Measure | Time frame |
|---|---|
| Tmax;T1/2;V/F;CL/F; | — |
Countries
China
Contacts
Public ContactGuoping Yang
Clinical Trial Center of the Third Xiangya Hospital of Central South University
Outcome results
None listed