NCT06248567已完成1 期
A Phase I Single Dose, Non-Randomised, Open-Label, Parallel Group Study to Investigate the Effect of Severe Kidney Impairment on the Pharmacokinetics, Safety and Tolerability of ZSP1273
Guangdong Raynovent Biotech Co., Ltd1 个研究点 分布在 1 个国家目标入组 16 人开始时间: 2024年1月15日最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- 入组人数
- 16
- 试验地点
- 1
- 主要终点
- Maximum observed plasma concentration (Cmax)
研究概览
简要总结
This study will assess the effect of severe kidney impairment on the pharmacokinetics (PK), safety and tolerability of ZSP1273.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Basic Science
- 盲法
- None
入排标准
- 年龄范围
- 15 Years 至 65 Years（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Body mass index (BMI) ≥18 to ≤28kg/m2 and total body weight >50 kg(male) or >40kg(female) at Screening (calculated as a function of measured height and weight according to the formula, BMI = kg / m2 where m2 is height in meters squared);
- •Ability to understand and willingness to sign a written informed consent form;
- •Participants with normal renal function only:
- •Normal physical examination, vital signs, 12-lead ECG, Chest X-ray images (anteroposterior) and clinical laboratory values, or any abnormality that is non-clinically significant.
- •Glomerular filtration rate (GFR)≥ 90 mL/min
- •Age, BMI, and sex comparable to those of subjects of severe renal impairment
- •Participants with severe renal impairment only:
- •Diagnosis of CKD (any indicators of renal impairment or GFR < 60 mL/min/1.73 m2 for more than 3 months)
- •glomerular filtration rate (GFR) between 15-29 mL/min (including boundary)
排除标准
- •Participants with an allergic disposition (multiple drug and food allergies) or who, as determined by the investigator, are likely to be allergic to the investigational drug product or any component of the investigational drug product.
- •Participants who donated blood or bleeding profusely (> 400 mL) in the 3 months.
- •Pregnant or lactating women, or women of childbearing age with a positive pregnancy test
- •Participants with serious infections, trauma, gastrointestinal surgery or other major surgical procedures within 4 weeks
- •Participants with severe renal impairment only:
- •Participants with acute renal failure, or a kidney transplant history; or requiring renal dialysis during the study period;
- •Hypertension that is not well controlled with antihypertensive medication (systolic blood pressure ≥ 160mm Hg or diastolic blood pressure ≥ 100mm Hg)
- •New York heart association (NYHA) class III or IV congestive heart failure
- •Alanine aminotransferase (ALT) ≥ 2×ULN, aspartate aminotransferase(AST) ≥ 2×ULN; Serum total bilirubin > 1.5×ULN;
研究组 & 干预措施
Experimental 1: participants with severe renal impairment
Experimental
8 participants with severe renal impairment will be given 600mg of ZSP1273
干预措施: ZSP1273 (Drug)
Experimental 2: healthy participants
Experimental
8 participants with normal renal function will be given 600mg of ZSP1273
干预措施: ZSP1273 (Drug)
结局指标
主要结局
Maximum observed plasma concentration (Cmax)
时间窗: 0~120hours
The Cmax of a single dose of ZSP1273 in participants with severe impaired renal function and controls with normal renal function will be evaluated and compared.
Area under the concentration-time curve from time zero to last time of quantifiable concentration (AUClast)
时间窗: 0~120hours
The AUClast of a single dose of ZSP1273 in participants with severe impaired renal function and controls with normal renal function will be evaluated and compared.
次要结局
- Number of participants with drug-related adverse events as assessed by CTCAE v5.0(DAY1~DAY12)
研究者
研究点 (1)
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