A Pharmacokinetic Study of HDM1005 Injection in Participants With Impaired Renal Function and Healthy Participants

Официальное название

A Multicenter, Single-Dose, Parallel-Group, Open-Label Pharmacokinetic Study of HDM1005 Injection in Participants With Impaired Renal Function and Healthy Participants

Обзор

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.

Вмешательства

• Препарат HDM1005
  2.0 mg, SC, single dose

Первичные конечные точки

• Maximum Concentration (Cmax) [Срок оценки: Up to Day 29]
• Area Under the Concentration Time Curve From Time Zero to t [ AUC(0- t)] [Срок оценки: Up to Day 29]

Вторичные конечные точки (3)

• Apparent clearance (CL/F) [Срок оценки: Up to Day 29]
• Apparent distribution(Vz/F) [Срок оценки: Up to Day 29]
• Adverse events (AEs) [Срок оценки: Up to Day 29]

Критерии участия

Критерии включения

• 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.

Критерии исключения

• 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.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Да

Дизайн исследования

Распределение

Нерандомизированное

Модель

Параллельные группы

Маскирование

Открытое

Основная цель

Лечение

Центры проведения

Китай · 1 центр

• Peking University Third Hospital — Пекин

Идентификаторы

NCT: NCT07559240 · HDM1005-105

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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