NCT07189962已完成1 期
A Pharmacokinetic Study of SHR8554 Injection in Chinese Patients With Renal Insufficiency and Healthy Subjects
干预措施
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 20
- 试验地点
- 1
- 主要终点
- Maximum observed concentration of SHR8554 (Cmax).
研究概览
简要总结
The study is being conducted to evaluate the safety and pharmacokinetic characteristics of SHR8554 injection in subjects with renal insufficiency and healthy subjects.
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 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Able and willing to provide a written informed consent;
- •The estimated glomerular filtration rate (eGFR) of subjects in groups must meet the corresponding standards;
- •Male or female;
- •with a body mass index (BMI) between 18.0 and 28.0 kg/m2.
排除标准
- •History of clinically significant allergies, known allergy to SHR8554, or any other structural analogs;
- •Subjects with positive tests for infectious diseases;
- •Pregnancy or lactation women, or a fertility male or female is not willing to contraception during test;
- •Unable to tolerate venipunctures or have a history of fainting needles and blood;
- •Historic abuse of alcoholic beverages;
- •Smoke ≥ 10 cigarettes per day within 3 months prior to the study;
- •History of drug abuse;
- •Diseases with abnormal clinical manifestations that occurred before screening or are currently occurring and need to be excluded for normal renal function group;
- •Vital signs, physical examination, 12-lead electrocardiogram, or laboratory examination deemed clinically significant by the investigator for normal renal function group;
- •History of renal transplantation and/or requirement for renal dialysis treatment during the study period for severe renal function group;
- •Urinary incontinence or anuria (e.g., < 100 mL/day) for severe renal function group;
- •Other reasons that the investigator consider it inappropriate to participate in the trial.
研究组 & 干预措施
Normal renal function group
Experimental
干预措施: SHR8554 Injection (Drug)
Severe renal dysfunction group
Experimental
干预措施: SHR8554 Injection (Drug)
结局指标
主要结局
Maximum observed concentration of SHR8554 (Cmax).
时间窗: 0 hour to 48 hours after administration.
Area under the serum concentration time curve (AUC) of SHR8554.
时间窗: 0 hour to 48 hours after administration.
Half-life (t1/2) of SHR8554.
时间窗: 0 hour to 48 hours after administration.
Clearance (CL) of SHR8554.
时间窗: 0 hour to 48 hours after administration.
Volume of distribution (Vz) of SHR8554.
时间窗: 0 hour to 48 hours after administration.
次要结局
- Cumulative excretion (Ae) of SHR8554.(0 hour to 48 hours after administration.)
- Urinary excretion fraction (fe) of SHR8554.(0 hour to 48 hours after administration.)
- Renal clearance (CLr) of SHR8554.(0 hour to 48 hours after administration.)
- Plasma protein binding rate of SHR8554 in patients with renal insufficiency.(0 hour to 48 hours after administration.)
研究者
研究点 (1)
Loading locations...
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