"Phase Ib Study of Z-213 in Subjects With Iron-deficiency Anemia - To Investigate the Safety, Tolerability Pharmacokinetics and Pharmacodynamics -"
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- 入组人数
- 24
- 试验地点
- 1
- 主要终点
- Pharmacokinetics of total serum iron (Cmax), (Tmax), (AUC0-t), (AUC0-24),(AUC0-72),(T1/2), (CL), (Vd, area), (Vd, ss), (MRT) or total urine iron (CLren), (Ae).
研究概览
简要总结
The safety, tolerability, pharmacokinetics and pharmacodynamics of Z-213 will be investigated in patients with iron-deficiency anemia after administration of a single dose (100 mg, 500 mg, 800 mg or 1,000 mg iron).
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 64 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients with mild iron deficiency anemia
排除标准
- •Patients with anemia caused by conditions other than iron deficiency
- •Patients with abnormal laboratory test values at screening for C-reactive protein, Serum phosphorus, Aspartate aminotransferase, Alanine aminotransferase, Total bilirubin
- •Patients with liver, kidney or circulatory system disease
- •Patients with a history or present illness that is a malignant tumor or autoimmune disease
- •Patients who underwent intravenous administration of an iron preparation, administration of an erythropoiesis stimulation agent or blood transfusion within 8 weeks before the screening
- •Patients who underwent oral administration of an iron preparation (including an over-the-counter drug or supplement) within 4 weeks before the screening
研究组 & 干预措施
Z-213 100mg
Group/Cohort Label: 100 mg iron Z-213 will be administered by intravenous infusion.
干预措施: Z-213 (Drug)
Z-213 500mg
Group/Cohort Label: 500 mg iron Z-213 will be administered by intravenous infusion.
干预措施: Z-213 (Drug)
Z-213 800mg
Group/Cohort Label: 800 mg iron Z-213 will be administered by intravenous infusion.
干预措施: Z-213 (Drug)
Z-213 1000mg
Group/Cohort Label: 1000 mg iron Z-213 will be administered by intravenous infusion.
干预措施: Z-213 (Drug)
结局指标
主要结局
Pharmacokinetics of total serum iron (Cmax), (Tmax), (AUC0-t), (AUC0-24),(AUC0-72),(T1/2), (CL), (Vd, area), (Vd, ss), (MRT) or total urine iron (CLren), (Ae).
时间窗: 8days
次要结局
未报告次要终点