The purpose of this study is to evaluate the pharmacokinetic profile and safety of a single subcutaneous injection of HDM1005 solution in participants with impaired kidney function compared to healthy participants.
Aged between 18 and 75 years (inclusive), regardless of gender.
Body weight ≥50.0 kg for males and ≥45.0 kg for females; body mass index (BMI) between 19.0 and 35.0 kg/m² (inclusive).
For participants with renal impairment: prior diagnosis of chronic kidney disease (CKD). Absolute GFR calculated by CKD-EPI and BSA formula: ≥30 and <60 mL/min for moderate impairment; ≥15 and <30 mL/min for severe impairment.
For participants with normal renal function: aged 18 to 75 years (inclusive); body weight ≥50.0 kg (male) or ≥45.0 kg (female); BMI 19.0-35.0 kg/m².
Personal or family history of medullary thyroid carcinoma (MTC), thyroid C-cell hyperplasia, or multiple endocrine neoplasia type 2 (MEN2).
History of chronic pancreatitis, or an episode of acute pancreatitis or acute cholecystitis within 3 months prior to screening.
Severe hypoglycemic events or recurrent hypoglycemic events (≥3 episodes per week) within 3 months prior to screening.
For the renal impairment group: presence of obstructive urinary tract disease, acute kidney injury, or other clinically significant systemic diseases beyond chronic kidney disease and its complications, which in the investigator's opinion make the participant unsuitable. For the normal renal function group: presence of clinically significant diseases involving any of the following systems at screening (including but not limited to respiratory, circulatory, digestive, hematopoietic, endocrine, immune, skin, nervous, psychiatric, ear-nose-throat, etc.), which in the investigator's opinion make the participant unsuitable.
Parallel
HDM1005
Drug2.0 mg, SC, single dose
Maximum Concentration (Cmax)
Cmax of HDM1005
Area Under the Concentration Time Curve From Time Zero to t [ AUC(0- t)]
AUC(0- t) of HDM1005
Apparent clearance (CL/F)
CL/F of HDM1005
Apparent distribution(Vz/F)
Vz/F of HDM1005
Adverse events (AEs)
Number of subjects reporting AEs
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