A Phase 1, Open-Label, Single Dose, Parallel-Group Study to Evaluate the Pharmacokinetics, Safety and Tolerability of MEDI0382 in Subjects With Renal Impairment
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 37
- 试验地点
- 1
- 主要终点
- Maximum Observed Concentration of MEDI0382 (Cmax)
研究概览
简要总结
A phase 1 open-label, single-dose study to evaluate the pharmacokinetics (PK), safety, tolerability and immunogenicity of MEDI0382 in subjects with renal impairment.
详细描述
This is an open-label, single-dose, parallel group study to evaluate the PK, safety, tolerability, and immunogenicity of MEDI0382 in subjects with renal impairment. Enrollment of approximately 40 subjects across multiple sites is planned. Subjects will be divided into 4 groups based on renal function.
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
- 18 Years 至 85 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Must provide written informed consent
- •BMI greater than or equal to 17 and less than or equal to 40 kg/m2
- •Creatinine clearance rate greater than or equal to 90 (healthy); or renally impaired (less than 60 mL/min)
- •Females of childbearing potential must use a highly effective form of contraception.
排除标准
- •Any history of or concurrent condition that in the opinion of the investigator would compromise the subjects safety.
- •Subjects on dialysis
- •Subjects with pancreatitis
- •Renal transplant subjects
- •Females pregnant or lactating
研究组 & 干预措施
Group 1: End Stage Renal Disease (ESRD)
Subjects with CrCl <20ml/min will receive MEDI0382 administered subcutaneously
干预措施: MEDI0382 (Drug)
Group 2: Severe and ESRD Subjects
Subjects with CrCl >20 and < 30 ml/min will receive MEDI0382 administered subcutaneously
干预措施: MEDI0382 (Drug)
Group 3: Healthy Subjects
Subjects with CrCl >90 ml/min will receive MEDI0382 administered subcutaneously
干预措施: MEDI0382 (Drug)
Group 4: Moderate Renal Disease
Subjects with CrCl > or equal to 30 and < 60 mL/min will receive MEDI0382 administered subcutaneously
干预措施: MEDI0382 (Drug)
结局指标
主要结局
Maximum Observed Concentration of MEDI0382 (Cmax)
时间窗: 0-48 hours
The first occurrence of the maximum observed plasma concentration determined directly from the raw concentration-time data
Area under the Concentration Time Curve (AUC) of MEDI0382
时间窗: 0-48 hours
The area under the plasma concentration-time curve to 48 hours concentration determined using the linear trapezoidal rule for increasing concentrations and the logarithmic trapezoidal rule for decreasing concentrations
次要结局
- Time to maximum observed concentration (Tmax)(0-48 hours)
- apparent clearance (Cl/F)(0-48 hours)
- AUCinf(0-48 hours)
- Half-life (T1/2)(0-48 hours)
- Anti-drug Antibody (ADA) titer(Day -1 to day 28)
- Number of subjects with Adverse Events(Study onset till 28 days post dosing)