A Pharmacokinetic Study of SHR8554 Injection in the Population With Renal Insufficiency and Healthy Participants

Inclusion criteria

• Able and willing to provide a written informed consent;
• The estimated glomerular filtration rate (eGFR) of subjects in groups must meet the corresponding standards;
• Male or female;
• with a body mass index (BMI) between 18.0 and 28.0 kg/m2.

Exclusion criteria

• History of clinically significant allergies, known allergy to SHR8554, or any other structural analogs;
• Subjects with positive tests for infectious diseases;
• Pregnancy or lactation women, or a fertility male or female is not willing to contraception during test;
• Unable to tolerate venipunctures or have a history of fainting needles and blood;
• Historic abuse of alcoholic beverages;
• Smoke ≥ 10 cigarettes per day within 3 months prior to the study;
• History of drug abuse;
• Diseases with abnormal clinical manifestations that occurred before screening or are currently occurring and need to be excluded for normal renal function group;
• Vital signs, physical examination, 12-lead electrocardiogram, or laboratory examination deemed clinically significant by the investigator for normal renal function group;
• History of renal transplantation and/or requirement for renal dialysis treatment during the study period for severe renal function group;
• Urinary incontinence or anuria (e.g., < 100 mL/day) for severe renal function group;
• Other reasons that the investigator consider it inappropriate to participate in the trial.