Phase 1 Single Dose, Double-blind, Dose-escalation, Safety, Tolerability and Pharmacokinetic Study of NCTX (PEGylated Liposomal Iodixanol Injection) in Healthy Volunteers
试验速览
- 阶段
- 1 期
- 状态
- 终止
- 入组人数
- 20
- 试验地点
- 1
- 主要终点
- Assessment of safety by clinical laboratory parameters, vital sign measurements, electrocardiograms, and adverse event monitoring
研究概览
简要总结
This is a randomized, double-blind, single dose, dose-escalation study to evaluate the safety, tolerability, and pharmacokinetics of NCTX (PEGylated Liposomal Iodixanol Injection) administered intravenously to healthy volunteers. In addition, computed tomography (CT) scans will be acquired to measure radiographic density in regions of interest (ROI) at times from 3-5 hours and up to 72 hours following NCTX administration.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Diagnostic
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 55 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Healthy, nonsmoking men and women 18 to 55 years of age
- •Body Mass Index (BMI) between 18.5 and 30.0 kg/m2
- •Serum creatinine within normal range and calculated creatinine clearance of 80 mL/min/1.73 m2 or greater
排除标准
- •Concurrent enrollment in another clinical trial or treatment with any investigational products or therapies within 30 days prior to dosing
- •History of infusion reactions to liposomes, nanoparticles, monoclonal antibodies, or intravenously administered materials
- •History of allergic/anaphylactoid-like reactions attributed to iodinated contrast agents or other components of the formulation
- •Disturbances in normal fat metabolism, or total cholesterol greater than 240 mg/dL
- •Pregnant or nursing women
- •Exposure to significant radiation within 1 year, or previous CT scan within 5 years prior to check-in
研究组 & 干预措施
Saline Placebo
2 of 8 subjects in each dose cohort will receive normal saline as a single intravenous infusion
干预措施: Saline Placebo (Drug)
NCTX
6 of 8 subjects in each dose cohort will receive NCTX (PEGylated Liposomal Iodixanol Injection) as a single intravenous infusion
干预措施: NCTX (PEGylated Liposomal Iodixanol Injection) (Drug)
结局指标
主要结局
Assessment of safety by clinical laboratory parameters, vital sign measurements, electrocardiograms, and adverse event monitoring
时间窗: Baseline and up to and including 28 days post drug administration
次要结局
- Maximum blood concentration (Cmax), half-life (t1/2), and ratio of free to encapsulated circulating iodixanol(Baseline and up to 28 days post drug administration)
- Radiographic density in ROIs by abdominal CT imaging(From 3-5 hours and up to 72 hours following NCTX administration)