NCT07070375已完成1 期
A Multicenter, Parallel-Group, Open-Label Study of Pharmacokinetics and Safety of HRS-8427 Injection in Chinese Subjects With Renal Impairment
干预措施
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 33
- 试验地点
- 1
- 主要终点
- Cmax
研究概览
简要总结
This study evaluated the pharmacokinetic profile, safety, and tolerability of HRS-8427 injection in subjects with mild, moderate, severe, or end-stage renal disease (ESRD) requiring dialysis, using subjects with normal renal function as controls, to inform clinical dosing in patients with renal impairment.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Male or female subjects aged between 18 and 70 years old (including the boundary values);
- •The body weight of male subjects should be ≥ 50.0 kg, and that of female subjects should be ≥ 45.0 kg. The body mass index (BMI = body weight (kg) / height² (m²)) should be between 18.0 and 32.0 kg/m² (including the boundary values);
- •The estimated glomerular filtration rate (eGFR) (estimated by the MDRD formula) needs to meet the following criteria:
- •For subjects with normal renal function: ≥ 90 mL/min and < 130 mL/min For subjects with mild renal insufficiency: 60 - 89 mL/min (including the boundary values) For subjects with moderate renal insufficiency: 30 - 59 mL/min (including the boundary values) For subjects with severe renal insufficiency: 15 - 29 mL/min (including the boundary values) For subjects with end-stage renal failure on maintenance dialysis: < 15 mL/min
- •The renal function status is stable. The interval between two detections during the screening period should be at least 72 hours (the result of the first detection can adopt the in-hospital or out-of-hospital detection result within 30 days before the second detection), and the absolute value of the fluctuation between the two detection results is less than 30%. Calculation formula: (the result of the second detection - the result of the first detection) / the result of the first detection;
- •Female subjects with fertility or male subjects whose partners are fertile females should have no plan for childbearing, donating sperm/eggs from the time of signing the informed consent form to 1 month after the last administration, and voluntarily take effective contraceptive measures (including partners) (non-drug contraception is required during the trial period).
排除标准
- •Subjects with a history of allergy to cephalosporins or penicillin, or those with specific allergic history (such as asthma, urticaria, eczema, etc.), or those with allergic constitution (such as being allergic to two or more drugs, foods and pollens);
- •Subjects who have undergone major surgeries within 3 months before screening, or those who have received surgeries that may significantly affect the in vivo process of the study drug or the evaluation of its safety, or those who plan to undergo surgeries during the trial period;
- •Subjects with a history of kidney transplantation or those who are expected to need kidney transplantation during the trial period;
- •Subjects who have been enrolled in any clinical trials as subjects within 3 months before screening;
- •Subjects with a positive result in any one of the tests for hepatitis B surface antigen, hepatitis C virus antibody, Treponema pallidum antibody or human immunodeficiency virus (HIV) during the screening period;
- •From 48 hours before taking the study drug until the end of the study, subjects refuse to stop consuming any beverages or foods containing methylxanthine, such as caffeine (coffee, tea, cola, chocolate, grapefruit and beverages containing this ingredient, etc.);
- •Subjects who frequently drink alcohol within 6 months before screening (that is, female subjects who drink more than 14 standard units of alcohol per week, and male subjects who drink more than 21 standard units of alcohol per week (1 standard unit contains 14g of alcohol, such as 360 mL of beer or 45 mL of liquor with an alcohol content of 40% or 150 mL of wine)) or those who cannot refrain from drinking alcohol during the trial period;
- •Subjects with abnormal results of 12-lead electrocardiogram that are judged by the research doctor to be clinically significant or with a corrected QTcF ≥ 450 ms, etc.;
- •Subjects who cannot refrain from smoking during the trial period;
- •Subjects with a history of drug abuse/drug use.
研究组 & 干预措施
Cohort A
Experimental
Healthy volunteer with stable normal renal function
干预措施: HRS-8427 (Drug)
Cohort B
Experimental
Patient with stable mild renal impairment
干预措施: HRS-8427 (Drug)
Cohort C
Experimental
Patient with stable moderate renal impairment
干预措施: HRS-8427 (Drug)
Cohort D
Experimental
Patient with stable severe renal impairment
干预措施: HRS-8427 (Drug)
Cohort E
Experimental
Patient with end-stage renal failure.
干预措施: HRS-8427 (Drug)
结局指标
主要结局
Cmax
时间窗: 4 days
observed maximum plasma concentration. Blood samples will be collected.
Ae: amount excreted. Urine samples will be collected.
时间窗: 4 days
AUC0-t
时间窗: 4 days
area under the plasma concentration-time curve from time 0 to the time of the last quantifiable concentration. Blood samples will be collected.
AUC0-∞
时间窗: 4 days
area under the plasma concentration-time curve from time 0 to infinity. Blood samples will be collected.
Tmax
时间窗: 4 days
observed time to reach Cmax. Blood samples will be collected.
次要结局
- Incidence of treatment emergent AEs (TEAEs)(no more than 14 days)
研究者
研究点 (1)
Loading locations...
相似试验
尚未招募
2 期
A Trial of Intravenous HRS-8427 in the Treatment of Adults With Complicate Urinary Tract Infection, Including Acute PyelonephritisPatients With Complicated Urinary Tract Infection(cUTI), Including Acute Pyelonephritis(AP)NCT06144060Jiangsu HengRui Medicine Co., Ltd.126
已完成
1 期
Pharmacokinetics Impact of HRS-8427 on Bupropion and Midazolam in Healthy SubjectsNCT07049107Jiangsu HengRui Medicine Co., Ltd.14
招募中
3 期
A Trial of HRS-8427 in the Treatment of Adults With Complicated Urinary Tract Infection, Including Acute PyelonephritisComplicated Urinary Tract Infection(cUTI), Including Acute Pyelonephritis(AP)NCT06569056Jiangsu HengRui Medicine Co., Ltd.578
已完成
2 期
A Trial of Intravenous HRS9432 in the Treatment of Subjects With Candidemia and/or Invasive CandidiasisPatients With Candidemia and/or Invasive CandidiasisNCT06194201Fujian Shengdi Pharmaceutical Co., Ltd.61
已完成
1 期
A Clinical Study to Compare the Safety and Pharmacokinetics of SHR-1314 Injection in Healthy Subjects at Different Specifications DevicesModerate-to-Severe Plaque PsoriasisNCT06182384Suzhou Suncadia Biopharmaceuticals Co., Ltd.46