NCT06547502已完成1 期
The Study of Pharmacokinetics and Safety of a Single Dose of GZR4 Injection in Subjects with Mild to Moderate Renal Impairment and Subjects with Normal Renal Function
Gan and Lee Pharmaceuticals, USA1 个研究点 分布在 1 个国家目标入组 16 人开始时间: 2024年7月3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
- AUC0-inf
研究概览
简要总结
This study will be conducted to investigated the effect of decreased kidney function on PK and safety of GZR4 and to guide dosing recommendations in people with kidney 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 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Male or female, aged 18-75 years (both inclusive) at the time of signing informed consent
- •Meeting the pre-defined Glomerular Filtration Rate (GFR) values
排除标准
- •Known or suspected hypersensitivity to trial product
- •Drugs known to affect creatinine clearance including cimetidine within 14 days or 5 half-lives prior to the day of dosing of GZR4 and during this trial
- •Individuals who routinely undergo dialysis or have a history of renal transplantation, hepatorenal syndrome, or acute kidney injury
研究组 & 干预措施
Normal renal function
Experimental
GFR between 90-130 ml/min
干预措施: GZR4 (Drug)
Mildly decreased renal function
Experimental
GFR between 60-90 ml/min
干预措施: GZR4 (Drug)
moderately decreased renal function
Experimental
GFR between 30-60 ml/min
干预措施: GZR4 (Drug)
结局指标
主要结局
AUC0-inf
时间窗: Day1-Day29
AUC0-last
时间窗: Day1-Day29
Cmax
时间窗: Day1-Day29
次要结局
- T1/2(Day1-Day29)
- Incidence of TEAE(Day1-Day29)
- AUC0-168h(Day1-Day29)
- Tmax(Day1-Day29)
研究者
研究点 (1)
Loading locations...
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