A Study to Evaluate the Pharmacokinetics of HSK21542 in Subjects With Renal Impairment

Inclusion Criteria: Subjects with renal impairment(RI): Voluntarily sign the informed consent form, understand the trial procedures, and be willing to comply with all trial procedures and restrictions; 18 years to 79 years (inclusive), male and female; Male subjects weight ≥50 kg and female subjects weight ≥45 kg. Body mass index (BMI) : 18-30 kg/m2 (inclusive) (BMI= weight (kg)/height2 (m^2)); Subjects with medically stable RI until study completion corresponding to the classifications of Renal Function based on GFR: mild RI: 60≤GFR<90 mL/min; moderate RI: 30≤GFR<60 mL/min, severe RI:15≤GFR<30 mL/min; Physical examination, vital sign measurements, 12-lead electrocardiogram (ECG), and clinical laboratory tests results were deemed appropriate by the investigator; Not in use of any drug within 2 weeks prior to screening, except for the medication necessary for RI/ other comorbidities (last more than four weeks in good compliance); Subjects (including partners) are willing to voluntarily use effective contraceptives from screening to at least 6 months after the last dose administration. Subjects with normal renal function : Voluntarily sign the informed consent form, understand the trial procedures, and be willing to comply with all trial procedures and restrictions; 18 years to 79 years (inclusive), male and female, age and sex must be matched with subjects with RI; Male subjects weight ≥50 kg and female subjects weight ≥45 kg, weight must be matched with subjects with RI. Body mass index (BMI) : 18-30 kg/m^2 (inclusive) (BMI= weight (kg)/height2 (m^2)); 90≤GFR<130 mL/min; Physical examination, vital sign measurements, 12-lead electrocardiogram (ECG), and clinical laboratory tests results were deemed appropriate by the investigator; Not in use of any drug within 2 weeks prior to screening, except for the medication necessary for comorbidities (last more than four weeks in good compliance); Subjects (including partners) are willing to voluntarily use effective contraceptives from screening to at least 6 months after the last dose administration. Exclusion Criteria: Subjects who have a allergic to any component of HSK21542 injection or allergic history to opiates, such as urticaria (opiate-related adverse reactions such as constipation and nausea are not included as exclusion criteria in this study); Have a history of severe and uncontrolled diseases, such as cardiovascular, respiratory, liver, gastrointestinal, endocrine, hematologic, mental/nervous systems diseases within one year prior to screening; Have conditions that may affect drug absorption, distribution, metabolism, or excretion (e.g., disease, drugs or surgery); Acute renal failure; Smoking more than 5 cigarettes per day within 3 months prior to screening or smoking during the study; Average alcohol intake is more than 14 unit per week (1unit=17.7 mL alcohol , 1 unit=357mL 5% alcohol beer, or 43mL 40% alcohol spirit, or 147mL 12% alcohol wine) within the 3 months prior to screening, or taking any alcohol during study or a positive ethanol breath test at screening; Drug abuse history within 5 years prior to screening, or positive urine drug screen at screening; History of high consumption of grapefruit juice, methylxanthine-rich food or beverage (such as coffee, tea, cola, chocolate, energy drinks) ,consumption of grapefruit juice, methylxanthine-rich food within 48 hours before the administration; Participation in another clinical trial within 3 months before screening; Blood donation (or blood loss) ≥400 mL, or receiving blood products to improve anemia within 3 months prior to the screening; Aspartate aminotransferase (AST), alanine aminotransferase (ALT) > 2 × upper limit of normal, or bilirubin > 1.5 × upper limit of normal; Have a positive result for hepatitis B surface antigen, hepatitis C virus antibody, human immunodeficiency virus antibody, or anti-treponema pallidum specific antibody; A pregnant/lactating woman, or has a positive pregnancy test at screening or during the trial; Not suitable for this study as judged by the investigator.