Obese, Overweight
Conditions
Brief summary
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.
Interventions
DRUGHDM1005
2.0 mg, SC, single dose
Sponsors
Hangzhou Zhongmei Huadong Pharmaceutical Co., Ltd.
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
Yes
Inclusion criteria
* 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. * In the investigator's opinion, suitable for the study based on medical history, clinical laboratory tests, vital signs, 12-lead ECG, and physical examination at screening. * Provide signed informed consent before any trial procedures; fully understand the trial content, procedures, and possible adverse reactions. * Able to communicate well with the investigator and understand and comply with all study requirements.
Exclusion criteria
* 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. * Known intolerance or allergy to GLP-1R and/or GIPR agonists, or known allergy to HDM1005 or any component of the formulation. * Major surgery within 6 months prior to screening, or incomplete healing of surgical incisions, or planned surgery during the study. * Blood donation or blood loss ≥400 mL, or use of blood products within 3 months prior to screening or between screening and dosing. * History of drug abuse (e.g., morphine, ketamine, tetrahydrocannabinolic acid, methamphetamine, methylenedioxymethamphetamine, cocaine) or positive urine drug test at screening. * History of needle phobia or hemophobia, difficulty with blood collection, or inability to tolerate venipuncture. * Any other condition (medical, psychological, psychiatric, social, or geographic factors) that, in the investigator's opinion, makes the participant unsuitable for the study.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Maximum Concentration (Cmax) | Up to Day 29 | Cmax of HDM1005 |
| Area Under the Concentration Time Curve From Time Zero to t [ AUC(0- t)] | Up to Day 29 | AUC(0- t) of HDM1005 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Apparent clearance (CL/F) | Up to Day 29 | CL/F of HDM1005 |
| Apparent distribution(Vz/F) | Up to Day 29 | Vz/F of HDM1005 |
| Adverse events (AEs) | Up to Day 29 | Number of subjects reporting AEs |
Countries
China
Contacts
CONTACTGuiyu Liu
Outcome results
None listed