An Open-label, Parallel-group, Single-center, Phase I Study to Compare the Pharmacokinetic/Pharmacodynamic Characteristics, Safety, and Tolerability of a Single Intravenous Administration of Efepoetin Alfa in Healthy Caucasian and Asian Volunteers
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- PharmacoKinetic parameters (AUClast)
研究概览
简要总结
An open-label, parallel-group, single-center, Phase I study to compare the pharmacokinetic/pharmacodynamic characteristics, safety, and tolerability of a single intravenous administration of Efepoetin Alfa in healthy subjects
详细描述
This study is to objectively evaluate pharmacokinetics as well as pharmacodynamic responses after a single intravenous administration of the Efepoetin alfa, GX-E4, in healthy Caucasian and Asian volunteers.
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
- 19 Years 至 45 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Adult males and females between the ages of 19-45
- •Asian or Caucasian
- •Body weight >50 kg and <90 kg, BMI 18 ~30 (BMI(kg/m2) = Weight(kg) / {Height(m)}2)
- •Normal hemoglobin range.
- •Normal Serum ferritin and transferrin saturation range.
- •Normal serum folate range
- •Normal vitamin B12 range
- •White blood cell >=3.0 X 10^3 /mm3
- •Platelet >= 150 X 10^3/mm^3 and <450 X 10^3/mm^3
- •Nonsmoker or smoker who smokes below 10 cigarettes a day.
排除标准
- •An allergy history, including drug allergies(example: aspirin, antibiotics, etc.) or clinically significant allergy.
- •Liver(including viral hepatitis), renal, respiratory, endocrine, neurological, immunological, blood, psychological, or circulatory system abnormalities, or a history of cancer.
- •Subject who had received EPO, darbepoetin, other EPO supply protein, or immunoglobulin administration, or had received intravenous iron administration.
- •Hypersensitivity to EPO and/or to the excipients of the IMP, or known hypersensitivity to supplementary iron products.
- •Hemoglobinopathy (homozygous sickle cell disease, all types of thalassemia)
- •Systolic blood pressure below 90mmHg or above 140mmHg, or diastolic blood pressure below 50mmHg or above 90mmHg after taking a rest over 3 minutes; pulse rate over 100bpm
- •C-reactive protein level >4mg/dL at 2 weeks prior to the IMP administration.
- •A drug abuse history, or positive in a urine drug-screening test(cocaine, amphetamines, barbiturates, opiates, benzodiazepine, and cannabinoids)
- •Signs of fever, with a temperature of over 38°C, within 1 week before particiation
- •History of epileptic seizure within 6 months before participation
- •Positive to HIV antibody, HBsAg, and HCV antibody test.
- •Consumes over 21 units of alcohol per week, or a person who cannot stay sober for the duration of the entire trial period.
- •Blood donation or a bleeding episode of more than 400mL within 8 weeks prior to study participation
- •The maximum length of the spleen >16cm.
- •Person thought inappropriate by the investigator in consideration of the laboratory test results.
- •Pregnant or breast-feeding.
研究组 & 干预措施
Asian
Single-dose
干预措施: Efepoetin Alfa (Drug)
Caucasian
Single-dose
干预措施: Efepoetin Alfa (Drug)
结局指标
主要结局
PharmacoKinetic parameters (AUClast)
时间窗: up to 4 weeks
To measure the concentration of Efepoetin alfa in serum for 336 hours after administration of the investigational product for the pharmacokinetic parameters area under the blood concentration-time curve
PharmacoKinetic parameters (Cmax)
时间窗: up to 4 weeks
To measure the concentration of Efepoetin alfa in serum for 336 hours after administration of the investigational product for the pharmacokinetic parameters peak blood concentration
次要结局
- PharmacoKinetic parameters (AUC0-t, AUCinf, AUC%Extrap, CL, tmax, Vd, t1/2)(up to 4 weeks)
- Pharmacodynamic parameters (Emax, ΔEmax, AUEC, ΔAUEC)(up to 4 weeks)