NCT03485053终止2 期
2 Part, Phase II Study of Intravenous, Single Ascending Dose Administrations of IOP Injection in Patients With Iron Deficient Anemia
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 终止
- 入组人数
- 49
- 试验地点
- 8
- 主要终点
- The mean difference in Hb from baseline
研究概览
简要总结
The purpose is to evaluate the efficacy and safety of IOP Injection (MPB-1514) for the treatment of iron-deficient anemia (IDA).
详细描述
The Phase II study is to establish the maximum tolerated dose of i.v. IOP Injection (MPB-1514) in Part 1 and to evaluate the safety and efficacy of the maximally tolerated dose of IOP Injection with different infusions schemes in Part 2.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Subject ≥ 18 years.
- •Subject with IDA but not secondary to any malignancy or renal failure requiring dialysis.
- •Hb levels <11.0 g/dL, Ferritin levels <200 ng/dL, Transferrin saturation (TSAT) < 20% at the Screening Visit.
- •Subject must have the ability to provide written, personally signed, and dated informed consent to participate in the study.
- •Subject must have an understanding, ability, and willingness to comply fully with study procedures and restrictions and to be available for clinic visits and follow-up procedures.
- •Female subject of child-bearing potential who is sexually active must use an effective method of birth control for at least one month prior to screening and agree to use an effective method of birth control until completion of participation in the study.
排除标准
- •Subject with known hemochromatosis, thalassemia, hemolytic anemia, receive red blood cell or whole blood transfusions within 90 days prior to enrollment.
- •Subject with a history of intravascular hemolysis.
- •Subject receiving any erythropoiesis-stimulating agent (ESA) therapy within 4 weeks prior to screenin.
- •Subject with a known sensitivity to any i.v. iron formulation
- •Subject with C-reactive protein > 20 mg/dL.
- •Subject with HBV, HCV, HIV.
- •Subject with known malignancy or severe renal failure requiring dialysis.
- •Subject with a recent (within 1 year of study drug administration) drug or alcohol abuse (including cannabis products) as defined in Diagnostic and Statistical Manual of Mental Disorders, 4th edition, Diagnostic Criteria for Drug and Alcohol Abuse.
- •Subject averages an intake of more than 21 units of alcohol per week (≥ 3 drinks per day) for men and 14 units of alcohol per week (≥ 2 drinks per day) for women (1 unit of alcohol equals approximately 250 mL of beer, 100 mL of wine or 35 mL of spirits).
- •Subject who has smoked or used smoking cessation or nicotine containing products (including but not limited to e-cigarettes, pipes, cigars, chewing tobacco, nicotine patches, nicotine lozenges, or nicotine gum) within 6 months of the first dose of study drug.
- •Subject with any factor, which in the opinion of the Investigator would jeopardize the evaluation or safety or be associated with poor adherence to the protocol.
- •Subject with psychiatric disorder precluding the understanding of information on study related topics or giving informed consent.
- •Subject who has received another investigational agent within 4 weeks prior to screening.
- •Subject undergoing major surgery or physical trauma within 90 days or with major burn injury covering > 20% of total body surface area.
- •Female subject who is pregnant or breast feeding.
研究组 & 干预措施
IOP Injection / MPB-1514
Experimental
Administered IV infusion
干预措施: IOP Injection / MPB-1514 (Drug)
结局指标
主要结局
The mean difference in Hb from baseline
时间窗: on Day 28
Evaluate in IDA patients by assessing changes in hemoglobin (Hb) levels after dosing
次要结局
- Pharmacokinetic analysis of IOP Injection: Peak Plasma Concentration(pre-dose to post-dose 24 hours)
- Pharmacokinetic analysis of IOP Injection: Half-life in Plasma(pre-dose to post-dose 24 hours)
- Pharmacokinetic analysis of IOP Injection: Area Under the Plasma Concentration versus time(pre-dose to post-dose 24 hours)
- The number of subjects with treatment-related serious adverse events(Day 0 to Day 28)
研究者
研究点 (8)
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