A Study of HRS-1301 Tablets in Healthy Subjects and Those With Impaired Kidney Function

Официальное название

A Single-dose, Open-label Phase I Clinical Trial Comparing the Pharmacokinetics, Safety and Pharmacodynamics of HRS-1301 Tablets in Subjects With Mild, Moderate and Severe Renal Insufficiency and Healthy Subjects

Обзор

The primary objective of this study is to evaluate pharmacokinetics of HRS-1301 tablets in subjects with impaired kidney function in comparison with healthy subjects, to develop dose recommendations for patients with renal impairment.

Вмешательства

• Препарат HRS-1301 Tablet
  HRS-1301 tablet, oral medication.

Первичные конечные точки

• Maximum concentration (Cmax). [Срок оценки: 0 hour to 8 days after dosing.]
• Area under the concentration-time curve from time zero to the time of the last quantifiable concentration (AUC0-last). [Срок оценки: 0 hour to 8 days after dosing.]
• Area under the concentration-time curve from time zero to infinity (AUC0-inf). [Срок оценки: 0 hour to 8 days after dosing.]

Вторичные конечные точки (9)

• Time of maximum concentration (Tmax). [Срок оценки: 0 hour to 8 days after dosing.]
• Area under the concentration-time curve from time zero to the end of the dosing interval tau (AUC0-tau). [Срок оценки: 0 hour to 8 days after dosing.]
• Elimination half-life (t1/2). [Срок оценки: 0 hour to 8 days after dosing.]
• Apparent clearance (CL/F). [Срок оценки: 0 hour to 8 days after dosing.]
• Apparent volume of distribution (Vz/F). [Срок оценки: 0 hour to 8 days after dosing.]
• Cumulative drug excretion in urine (Ae,urine). [Срок оценки: 0 hour to 6 days after dosing.]
• Cumulative drug excretion fraction in urine (fe,urine). [Срок оценки: 0 hour to 6 days after dosing.]
• Incidence of adverse events (AEs). [Срок оценки: 0 hour to 8 days after dosing.]
• Incidence of serious adverse events (SAEs). [Срок оценки: 0 hour to 8 days after dosing.]

Критерии участия

Критерии включения

• Sign the informed consent before the trial, and fully understand the content, process, and possible adverse reactions of the trial;
• Male or female subjects aged 18 to 65 (including 18 and 65);
• Body mass index (BMI) ranges from 18 kg/m2 to 30 kg/m2 (including 18 and 30),and Male weight ≥ 50.0 kg, female weight ≥ 45.0 kg;
• The glomerular filtration rate should meet the following criteria (GFR, mL/min): Subjects with mild renal impairment: 60-89 mL/min; Subjects with moderate renal impairment: 30-59 mL/min; Subjects with severe renal function impairment: 15\~29 mL/min.

Критерии исключения

• Individuals with a specific history of allergies (such as asthma, urticaria, eczema, etc.), or those with an allergic constitution (such as those allergic to any drug or food), or those known to be allergic to any component of the studied drug;
• Those with cardiogenic shock, severe conduction obstruction, sick sinus syndrome, heart failure (NYHA grade III-IV), persistent rapid arrhythmia, tortuous ventricular tachycardia or ventricular tachycardia at the pointed point, a history of clinically significant T-wave changes, myocardial infarction, or angina pectoris;
• Suffering from malignant tumors, or having a history of malignant tumors within 5 years prior to screening (excluding skin non-melanomas that have been treated without recurrence signs and resected cervical intraepithelial neoplasia);
• Those with a history of gastric or intestinal surgery that some researchers believe may affect drug absorption;
• Those who have suffered severe trauma or undergone major surgical operations within the three months prior to screening, or who plan to undergo surgery during the trial period;
• Those who have participated in any clinical trials of drugs or medical devices within three months prior to screening, or those who are still within five half-lives of the drug before screening (whichever is longer);
• Those who have donated blood of ≥ 400 mL within 4 weeks before screening, or have suffered severe blood loss (blood loss ≥ 400 mL), or have received blood transfusion within 8 weeks;
• Those who received live (attenuated) vaccines within 4 weeks prior to screening or those who plan to receive them during the trial;
• Those with potential difficulties in blood collection and a history of fainting at the sight of needles or blood;
• For patients with renal insufficiency,those who have received renal replacement therapy (such as peritoneal dialysis, hemodialysis, etc.) within 3 months prior to the screening or during the expected trial period;
• For patients with renal insufficiency，screening individuals with underlying diseases that induce chronic kidney disease within the previous three months and are judged by researchers to be poorly controlled, such as diabetic patients with HbA1c > 10%, and hypertensive patients with systolic blood pressure > 180 mmHg and diastolic blood pressure > 120 mmHg, etc.

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

Здоровые добровольцы: Да

Дизайн исследования

Распределение

Не применимо

Модель

Одна группа

Маскирование

Открытое

Основная цель

Лечение

Центры проведения

Китай · 1 центр

• Sichuan Provincial People's Hospital — Чэнду

Идентификаторы

NCT: NCT07322016 · HRS-1301-103

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

Открыть это исследование на ClinicalTrials.gov ↗