A Phase 1/2, Open Label, Randomized Study of Low Concentration Ioforminol Injections for Use in Contrast-Enhanced Abdominal Computed Tomography in Healthy Volunteers
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 66
- 试验地点
- 1
- 主要终点
- Radiographic Densities at Selected Regions in Contrast-enhanced CT Examination by Location (Abdominal Aorta), kVp 80 and Contrast Type (Ioforminol vs Iopamidol), Concentration (Ioforminol 160 or 200) and Dose Levels (1.0, 1.5, and 2.0mL/kg).
研究概览
简要总结
To optimize both the Ioforminol concentration and dosage(s) for CECT of the abdomen. To evaluate the safety and tolerability of low concentration Ioforminol Injections. Study recruits healthy volunteers.
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
- None
入排标准
- 年龄范围
- 18 Years 至 50 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Healthy males or females between 18 and 50 years of age.
- •The subject has a maximum abdominal circumference of 120 cm or less.
排除标准
- •The subject has known Grade 3 or 4 allergic reaction/hypersensitivity to either iodine or any iodinated-based contrast agent or with history of multiple allergies (i.e., foods, pets, medications, etc).
- •The subject has chronic renal insufficiency (estimated glomerular filtration rate [eGFR] <60 mg/dL) as measured at the screening visit.
- •The subject is pregnant or breast-feeding.
- •The subject has suspicion or diagnosis of hyperthyroidism or autonomously functioning thyroid nodule confirmed by T3, T4, and/or thyroid-stimulating hormone.
- •The subject has severe liver or hematologic diseases (sickle cell disease or multiple myeloma), or immunodeficiency.
- •The subject is taking metformin (e.g., Glucophage®) therapy.
研究组 & 干预措施
Arm 1 - Ioforminol 160mgI/mL
Single administration of Ioforminol 160mgI/mL given to the subject.
干预措施: Ioforminol 160 mgI/mL (Drug)
Arm 2 - Ioforminol 200mgI/mL
Given as a single administration to the subject
干预措施: Ioforminol 200 mgI/mL (Drug)
Arm 3 - Iopamidol 300mgI/mL
Given as a single administration to the subject
干预措施: Iopamidol 300 mgI/mL (Drug)
结局指标
主要结局
Radiographic Densities at Selected Regions in Contrast-enhanced CT Examination by Location (Abdominal Aorta), kVp 80 and Contrast Type (Ioforminol vs Iopamidol), Concentration (Ioforminol 160 or 200) and Dose Levels (1.0, 1.5, and 2.0mL/kg).
时间窗: Within 5 minutes after administration for either Ioforminol or Iopamidol.
Quantitative measurement of the radiographic density (as measured by Hounsfield Units (HU) ) at the abdominal aorta at the level of the celiac artery. The greater the contrast attenuation, the higher the HU.
Radiographic Densities at Selected Regions in Contrast-enhanced CT Examination by Location (Abdominal Aorta), kVp 100 and Contrast Type (Ioforminol vs Iopamidol), Concentration (Ioforminol 160 or 200) and Dose Levels (1.0, 1.5, and 2.0mL/kg).
时间窗: Within 5 minutes after administration for either Ioforminol or Iopamidol.
Quantitative measurement of the radiographic density (as measured by Hounsfield Units (HU) ) at the abdominal aorta at the level of the celiac artery. The greater the contrast attenuation, the higher the HU.
次要结局
- Evaluate the Overall Safety of Ioforminol and Iopamidol Injections by Recording Treatment Emergent Adverse Events (TEAE).(Up to 72 hours for safety monitoring post Ioforminol and Iopamidol administration.)