A Randomized, Double-blind Placebo Controlled, Single-dose Study to Investigate the Safety, Tolerability, and Pharmacokinetics/Pharmacodynamics of GX-E2 After Single Intravenous Administration in Healthy Subjects
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 10
- 试验地点
- 1
- 主要终点
- pharmacokinetics as measured by Cmax AUC(0-tlast)
研究概览
简要总结
This is a randomized, placebo controlled, single dose study to assess the safety, tolerability, pharmacokinetics and pharmacodynamics of GX-E2 in healthy male subjects.
详细描述
The purpose of this study is to investigate the safety, tolerability and pharmacokinetics of GX-E2 when given as single dose (GX-E2 8 ug/kg) to healthy male subjects. Additionally, Immunogenecity will be evaluated to investigate antibody production.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 20 Years 至 55 Years（Adult）
- 性别
- Male
- 接受健康志愿者
- 是
入选标准
- •Written informed consent
- •Male subjects 20 to 55 years old
- •Adequate body weigth and BMI(19 ≤ BMI ≤ 27, 60.0kg ≤ body weigth ≤ 90.0kg)
- •The subject doesn't have a clinically significant abnormal laboratory value and/or clinically significant unstable medical or disease history.
- •Are eligible for the study hemoglobin data(12.0g/dL ≤ Hb ≤ 16.5g/dL) (Data is checked per 2 weeks within 28 days)
- •Adequate transferrin saturation, serum ferritin within 28 days
- •Adequate folate within 28 days
- •Adequate vitamin B12 within 28 days
- •Adequate WBC count (≥ 3.0 X 1000 µL)
- •Adequate PLT count(≥ 140 X 1000 µL)
- •nonsmoker or smoker smoked under 10 cigarettes a day
排除标准
- •The subject has a clinically significant abnormal allergy including medical allergy.
- •The subject has evidence of clinically significant gastrointestinal, cardiovascular, hepatic, renal, hematological, neoplastic, endocrine, neurological, immunodeficiency, pulmonary, or other disorder or disease
- •Subject with a previous experience in i.v. administration of EPO, darbepoetin, other EPO supplying proteins, immunoglobulin and iron drugs
- •Subject with a hypersensitivity against EPO, darbepoetin and supplementary iron drugs
- •Subject with a condition of hemoglobinopathy (e.g. sickle-cell disease and thalassemia)
- •Subject showing following systolic and diastolic parameters at sitting position after 3 minutes of resting: lower than 90 mmHg or higher than 140mmHg of systolic blood pressure and lower than 50 mmHg or higher than 90mmHg of diastolic blood pressure
- •Subject with chronic and uncontrollable symptoms of inflammatory disease (e.g. rheumatoid arthritis and systemic lupous erythematousus)
- •Subject with the exceeding level of C-reactive protein more than 4 mg/dL before 2 weeks of IP administration
- •History of drug prior to screening or urine drug testing is positive (cocaine, amphetamines, barbiturates, opiates, benzodiazepine, cannabinoids)
- •Subject who has administered with a prescribed drug and oriental or herbal medicine in 2 weeks before IP administration, and who has administered with a general pharmaceutical and vitamin in 1 week before IP administration
- •Subject who has enrolled in other clinical trials of IP or approved drug within 8 weeks before IP administration
- •Subject with a history of fever at body temperature more than 38°C in a week before IP administration
- •History of epileptic convulsion within 6 months
- •Subject who is positive in HIV, HBsAg, HCV antibody test
- •Subject with a regular alcohol consumption more than 21 unit, and who is unable to quit drinking during the period of clinical trial
- •Subject who donated or lost more than 400mL of blood within 8 weeks prior to first dose
- •Subject who is treated with investigational products.
- •Subject with a longer length of spleen more than 16cm via upper abdominal ultrasound during the screening
- •Subject who is considered as inappropriate for participation by Investigator based on various lab results
- •Subject who plans to be pregnant or at least is unable to apply authorized contraceptive methods (e.g. sterilization operation, the use of contraceptive devices)
研究组 & 干预措施
Group A
Drug : GX-E2 - Intravenously injection once day at dose 8 ug/kg Drug : Placebo
(1 subject : GX-E2, 1 subject : Placebo)
Subjects in group A will be injected drug, So we observe safety. After three days, Subject in group B will be injected drug.
干预措施: GX-E2 (Drug)
Group B
Drug : GX-E2 - Intravenously injection once day at dose 8 ug/kg Drug : Placebo (7 subjects : GX-E2, 1 subject : Placebo)
干预措施: GX-E2 (Drug)
结局指标
主要结局
pharmacokinetics as measured by Cmax AUC(0-tlast)
时间窗: Day1 - 29
Measures "Cmax, AUC(0-tlast), AUCing, Tmax, t1/2 and CL/F after single dose of 8ug/kg GX-E2"
pharmacokinetics as measured by Cmax
时间窗: Day1 - 29
Measures "Cmax, AUC(0-tlast), AUCing, Tmax, t1/2 and CL/F after single dose of 8ug/kg GX-E2"
pharmacokinetics as measured by CL/F
时间窗: Day1 - 29
Measures "Cmax, AUC(0-tlast), AUCing, Tmax, t1/2 and CL/F after single dose of 8ug/kg GX-E2"
pharmacokinetics as measured by AUCing
时间窗: Day1 - 29
Measures "Cmax, AUC(0-tlast), AUCing, Tmax, t1/2 and CL/F after single dose of 8ug/kg GX-E2"
pharmacokinetics as measured by Tmax
时间窗: Day1 - 29
Measures "Cmax, AUC(0-tlast), AUCing, Tmax, t1/2 and CL/F after single dose of 8ug/kg GX-E2"
pharmacokinetics as measured by t1/2
时间窗: Day1 - 29
Measures "Cmax, AUC(0-tlast), AUCing, Tmax, t1/2 and CL/F after single dose of 8ug/kg GX-E2"
次要结局
- Safety and Tolerability of GX-E2 as checked immunogenecity(Day1 - 29)
- pharmacodynamics as measured by Hemoglobin(Day1 - 29)
- pharmacodynamics as measured by Reticulocyte hemoglobin contents(Day1 - 29)
- pharmacodynamics as measured by Reticulocyte count(Day1 - 29)