Phase I Dose-escalation Trial of the Safety, Pharmacokinetics, and Pharmacodynamics of Iron Isomaltoside (Monofer®) Administered as Single Bolus Injections or Infusions in Japanese Subjects With Iron Deficiency Anemia
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 24
- 试验地点
- 1
- 主要终点
- Proportion of adverse events
研究概览
简要总结
The trial is an open-label, 4 cohorts, sequential, dose-escalating, single dose trial.
详细描述
IDA is highly prevalent in subjects with cancer and gastrointestinal diseases such as inflammatory bowel diseases, menstruating or pregnant women, and subjects who have undergone bariatric procedure. IDA can have a substantial medical and quality of life (QoL) burden on the subjects, and treatment of these subjects includes controlling the bleeding and replenishing lost iron.
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
- 20 Years 至 64 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Japanese man or woman ≥ 20 years, < 65 years of age
- •Hb of ≥ 9.0 g/dL, < 12.0 g/dL for women and < 13.0 g/dL for men
- •Serum ferritin < 25 ng/mL
- •TIBC ≥ 360 μg/dL
- •Body weight ≥ 50 kg
- •Willingness to participate and signing the informed consent form
- •Exclusion criteria include:
- •Anemia caused by conditions other than iron deficiency
- •IV or oral iron treatment, or blood transfusion 4 weeks prior to screening
- •Erythropoiesis stimulating agent (ESA) treatment prior to screening
- •Imminent expectation of blood transfusion on part of treating physician
- •Iron overload or disturbances (e.g. hemochromatosis and hemo-siderosis)
- •Known hypersensitivity reaction to iv iron preparations
- •Decompensated liver cirrhosis or active hepatitis
- •Active acute or chronic infections
- •Pregnant or nursing women.
- •Planned elective surgery during the trial
排除标准
- 未提供
研究组 & 干预措施
cohort 1 iron isomaltoside
treated with first dose level of iron isomaltoside
干预措施: Iron Isomaltoside (Drug)
cohort 2 iron isomaltoside
treated with second dose level of iron isomaltoside
干预措施: Iron Isomaltoside (Drug)
cohort 3 iron isomaltoside
treated with third dose level of iron isomaltoside
干预措施: Iron Isomaltoside (Drug)
cohort 4 iron isomaltoside
treated with fourth dose level of iron isomaltoside
干预措施: Iron Isomaltoside (Drug)
结局指标
主要结局
Proportion of adverse events
时间窗: 1 week
Proportion of adverse events will be collected and evaluated for relatedness, severity, seriousness, and expectedness.
次要结局
- Time to reach maximum drug concentration [Tmax](1week)
- Change in concentration of hemoglobin (g/dL)(1 week)
- Change in concentration of serum ferritin (ng/mL)(1 week)
- Time to reach one-half of the maximum drug concentration [T1/2](1 week)
- Maximum plasma drug concentration [Cmax](1 week)
- Area Under the Curve [AUC](1 week)
- Change in concentration of total iron binding capacity (μg/dL )(1 week)
- Change in concentrations of transferrin saturation (%)(1 week)