A Randomized, Positive-controlled, Single-dose, Dose-escalation Phase I Trial to Evaluate Safety & Tolerability, and Explore the Pharmacokinetics and Pharmacodynamics Profile of Pegylated rhEPO in Male Healthy Individual
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 150
- 试验地点
- 1
- 主要终点
- Serum concentration of rhEPO
研究概览
简要总结
The object of this randomized, parallel, positive controlled study is to explore the pharmacokinetics and pharmacodynamics profile of the test drug after single-dose subcutaneous administration, compared to the comparator drug (EPIAO®) after multiple-dose subcutaneous administration, by assessing plasma concentration of the drug and the reticulocyte count, hemoglobin concentration and hematocrit following subcutaneous administration, evaluate the security and tolerability of the test drug in healthy subjects, and provide sufficient information for dose selection in the future phase II and III study.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 40 Years（Adult）
- 性别
- Male
- 接受健康志愿者
- 是
入选标准
- •Agree to all the purposes of the study by signing and dating the informed consent.
- •Male, aged between 18 and 40 years, age disparity of each group should less than 10 years.
- •Body weight ≥ 50kg, and body mass index (BMI) between 18 kg/m2 and 26kg/m2 at screening.
- •Hemoglobin between 131g/L and 162g/L, hematocrit between 41% and 49%, and reticulocyte between 0.5% and 2%.
- •Transferrin saturation and serum ferritin are in the normal range.
- •Physical condition: vital signs, physical examination and laboratory tests ( including routine blood, biochemical tests, coagulation indicators, serum folic acid, vitamin B12, urine test, HBsAg, anti-HCV, anti-HIV, Immunoglobulin (IgA, IgM, IgG), thyroid function (T3, T4, TSH), autoantibodies), chest-X-ray, 12-lead ECG should all in normal range, or without significant clinically abnormal.
排除标准
- •Presence of organic disease in heart, liver, kidney, brain; or presence of cardiovascular, pulmonary, gastrointestinal, urinary, neurological, endocrine, immunity, genitourinary or other systems disease.
- •Subjects with familial genetic disease, mental illness, or physical disability.
- •History of drug allergy.
- •Orthostatic hypotension, systolic blood pressure <90mmHg.
- •Habitual medication, including Chinese herbal medicine.
- •Poor inclusion conditions (e.g. infirm).
- •Smoker (smoke everyday or more than 7 cigarettes per week)，alcoholics (more than 40g/day, equivalent to 100ml/day of 50 degree of white spirit).
- •Participate in any other drug trials as the subjects within the previous 3 months.
- •As blood donated within the previous 3 months, or experienced massive blood loss due to trauma or surgery.
- •Other conditions which in the opinion of the investigator precluding enrollment into the study (e.g. poor compliance).
研究组 & 干预措施
Pegylated rhEPO
Subcutaneous single-dose administration of 0.5mcg/kg, 1.0mcg/kg, 1.6 mcg/kg, 2.4 mcg/kg, 3.2 mcg/kg，3.2mcg/kg, 4.2mcg/kg, 5.5 mcg/kg, 7.2 mcg/kg, 9.3 mcg/kg (in dose-escalation, if the previous dose is confirmed to be safe.started with the second 3.2mcg/kg dose,Every subject takes Niferex 150mg every day, from day 1 to day 20. ) of the test drug (Pegylated rhEPO)
干预措施: Pegylated rhEPO (Drug)
EPIAO®
Subcutaneous six-dose administration of 50IU/kg or 150IU/kg, as randomization, of the comparator drug(EPIAO®) at day 1, 3, 5, 8, 10, 12.
干预措施: EPIAO® (Drug)
结局指标
主要结局
Serum concentration of rhEPO
时间窗: 0 hour before drug administration and 1, 3, 6, 9, 12, 14, 16, 24, 36, ,48, 72, 96, 120, 144, 168, 192, 216,240, 264, 288, 300, 312, 360, 408, 480, 648, 984,1320 hour after drug administration
* Time frame of day 12 for comparator drug: 0 hour before drug administration and 1, 3, 6, 9, 14, 16 hour after last dose administration. * For comparator drug, blood collection of 0, 48, 96, 168, 216, and 264 hour should before drug administration.
Plasma reticulocyte count
时间窗: 0 hour before and 24, 48, 72, 96, 120, 144, 168, 192, 216, 240, 264, 288, 312, 360, 408, 480, 648,984,1320 hour after first drug administration.
For comparator drug, blood collection of 48, 96, 168, 216, and 264 hour should before drug administration
Plasma hemoglobin concentration
时间窗: 0 hour before and 24, 48, 72, 96, 120, 144, 168, 192, 216, 240, 264, 288, 312, 360, 408, 480, 648,984,1320 hour after first drug administration.
For comparator drug, blood collection of 48, 96, 168,216, and 264 hour should before drug administration
Plasma hematocrit
时间窗: 0 hour before and 24, 48, 72, 96, 120, 144, 168, 192, 216, 240, 264, 288, 312, 360, 408, 480, 648,984,1320 hour after first drug administration.
For comparator drug, blood collection of 48, 96, 168,216, and 264 hour should before drug administration
次要结局
未报告次要终点