A Pharmacokinetic Study of HDM1005 Injection in Participants With Impaired Renal Function and Hea… (NCT07559240) | Clinical Trial Compass
Not Yet RecruitingPhase 1
A Pharmacokinetic Study of HDM1005 Injection in Participants With Impaired Renal Function and Healthy Participants
China30 participantsStarted 2026-05-15
Plain-language 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.
Who can participate
Age range18 Years – 75 Years
SexALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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 d…
What they're measuring
1
Maximum Concentration (Cmax)
Timeframe: Up to Day 29
2
Area Under the Concentration Time Curve From Time Zero to t [ AUC(0- t)]