About this trial
This study aims to evaluate the pharmacokinetic effects of a single dose of HRS-4729 injection in participants with mild, moderate, and severe renal impairment, with 8 participants enrolled in each renal impairment group and 8 healthy participants.
Eligibility criteria
This trial accepts healthy volunteersQualifiers
Provide written informed consent prior to any study-related procedures, and have a full understanding of the study content, procedures, and potential adverse events.
Be aged 18 to 65 years (inclusive), of either sex.
Have a body mass index (BMI) between 19 and 40 kg/m² (inclusive).
Glomerular filtration rate (absolute eGFR) must meet the relevant requirements and criteria specified in the protocol.
Disqualifiers
Have a history of significant abnormal gastric emptying, severe gastrointestinal disease, or gastrointestinal surgery (except gastrointestinal polypectomy), as assessed by the investigator to be unsuitable for participation.
Have a history or family history of medullary thyroid carcinoma or multiple endocrine neoplasia type 2 (MEN2), or a history of pancreatitis or symptomatic cholelithiasis.
Have a history of malignancy in any organ system within the past 5 years, regardless of evidence of local recurrence or metastasis, with the exception of cured localized basal cell carcinoma of the skin, carcinoma in situ of the cervix, and carcinoma in situ of the prostate.
Have undergone any surgery within 6 months prior to dosing, or plan to undergo surgery during the study period (excluding gastrointestinal polypectomy).
Trial design
Parallel
Treatments tested in this trial
HRS-4729
DrugEach subject will receive a single subcutaneous dose of HRS-4729 injection solution.
Treatment groups
Trial outcomes
Primary outcomes
Cmax
AUC0-t
AUC0-inf.
Secondary outcomes
Tmax
CL/F
Vz/F
t1/2
Sponsors and contacts
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