None listed
Conditions
Interventions
Subjects with mild renal insufficiency: Single subcutaneous injection of PB-119
Subjects with moderate renal insufficiency:Single subcutaneous injection of PB-119
Matched Normal renal function subjects:Single subcutaneous injection of PB-119
Sponsors
West China Hospital of Sichuan University
Eligibility
Sex/Gender
All
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: All subjects must meet all of the following criteria for inclusion in the study: 1. Be willing to sign ICF before the activities related to the study, understand the procedures and methods of the study, and be willing to complete the study strictly in accordance with the clinical study protocol; 2. Male subjects: Male subjects will voluntarily use effective contraceptive measures and shall not donate sperm from the screening period to 90 days after administration of the study drug Female subjects are required to meet one of the following conditions: ? Non-fertile women ? Fertile women (WOCBP) voluntarily used effective contraception from the screening period until 90 days after the study drug was administered; 3. Physical examination, vital signs examination, 12-lead ECG examination and laboratory examination were determined by the investigator to be suitable for this study; The subjects in the renal insufficiency group should also meet the following criteria: 4. Male or female subjects between the ages of 18 and 75; 5. The weight of male subjects should not be less than 50 kg, and that of female subjects should not be less than 45 kg. BMI between 18 and 30 kg/m2 (both values included); 6. Subjects were diagnosed as chronic (& GT; 3 months), stable (no acute exacerbation due to renal deterioration within 1 month prior to screening), and GFR measured during screening period was 60 89 mL/min (mild renal insufficiency in group A) or 30-59 mL/min (moderate renal insufficiency in group B). Renal function was evaluated by eGFR calculated by CKD-EPI formula and converted into individual GFR. Subjects in the normal renal function group should also meet the following criteria: 7. Male or female subjects between the ages of 18 and 75 years were matched for age (±10 years) and sex with subjects in the renal insufficiency group; 8. The weight of male subject should not be less than 50 kg, and that of female subject should not be less than 45 kg. BMI of 18 to 30 kg/m2, including both values, matched with BMI (±15%) in the renal insufficiency group; 9. GFR=90 and < in subjects with normal renal function; 130 mL/min (estimated by CKD-EPI formula).
Exclusion criteria
Exclusion criteria: All subjects will not be included in the study if they meet any of the following criteria: 1. Allergic constitution, or allergic to any component in PB-119; 2. Patients with a previous history or family history of medullary thyroid cancer (MTC) or type 2 multiple endocrine adenomatosis (MEN2), or with serum calcitonin =50 pg/mL at screening; 3. Serum amylase or lipase & GT at screening stage or baseline; 3× upper limit of normal value (ULN) or previous diagnosis of acute/chronic pancreatitis; 4. Screened subjects with severe gastrointestinal diseases (such as active ulcer, gastroparesis, pyloric obstruction, inflammatory bowel disease, etc.) or gastrointestinal surgery or long-term use of drugs that directly affect gastrointestinal motility due to chronic gastrointestinal diseases within the previous 6 months or baseline period are not suitable for the clinical study as assessed by the investigator; 5. Patients with any type of treated or untreated malignant tumor (whether cured or not) in the 5 years prior to screening or at baseline (except basal cell carcinoma of the skin); 6. Patients who had a major illness or surgery in the 4 weeks prior to administration, or who were projected to be hospitalized for surgery or other reasons during the study period; 7. Those with a history of drug abuse or positive urine drug screening test within 5 years prior to screening; 8. Those who smoked more than 10 cigarettes per day in the 3 months prior to screening; 9. 3 months prior to screening the average amount of alcohol consumed more than 14 units a week (women) or 21 units (male subjects) (1 unit of alcohol is equivalent to 284 mL of beer, 1 cup of 125 mL of wine or 25 mL liquor), or to 48 hours before taking any alcoholic products, or test positive for alcohol breath; 10. Clinical investigator who participated in any drug or medical device within 3 months prior to screening (subject to drug administration); 11. Blood donation (or blood loss) =400 mL within 3 months before screening, or receiving blood products; 12. Acute hepatitis, chronic liver disease, or screening or baseline alanine aminotransferase (ALT) or aspartate aminotransferase (AST) & GT; 2×ULN, total bilirubin & GT; 2 x ULN. 13. Positive for hepatitis B surface antigen (HBsAg), hepatitis C virus antibody, human immunodeficiency virus (HIV) antibody or treponema pallidum antibody according to any of the diagnostic tests used locally; 14. Female subjects with positive pregnancy test results during screening or baseline; 15. Novel Coronavirus nucleic acid test positive in screening or baseline period; 16. Unable to perform venipuncture and/or tolerate catheter venous access; 17. The Investigator considers that the subject is not suitable to participate in the study due to any conditions that may cause the subject to fail to complete the study or bring significant risks to the subject or other factors that may reduce the possibility of enrollment; Subjects in the renal insufficiency group will not be included in the study if they meet any of the following criteria: 18. patients with obstructive urinary tract disease (e.g., urinary calculi, abdominal space-occupying lesions caused by urinary tract obstruction, etc.) or other nature and renal dysfunction (such as polycystic kidney and kidney tumors, etc.) and/or cause renal damage unrelated kidney disease (e.g., renal artery stenosis, drugs, severe infections, insufficient blood volume, heart failure, etc.) of renal da
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| AUC0-inf;AUC0-t;Cmax; | — |
Secondary
| Measure | Time frame |
|---|---|
| Tmax;T1/2;Vz/F;CL/F;?z;MRT;AUC%extrapolated;Evaluation of the correlation between renal function indicators and PK parameters;safety; | — |
Countries
China
Contacts
Public ContactJia Miao / Ping Fu
West China Hospital of Sichuan University
Outcome results
None listed