A Dose-Block Randomized, Double-blind Placebo Controlled, Open-label Active Controlled, Dose-escalation Study to Investigate the Safety, Tolerability, and Pharmacokinetics/Pharmacodynamics of GC1113 After Single Intravenous/Subcutaneous Administration in Healthy Male Subjects
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 100
- 主要终点
- Safety/ Tolerability Evaluation
研究概览
简要总结
This is a Dose-Block Randomized, Double-blind Placebo controlled, Open-label Active controlled, Dose-escalation Study to investigate the safety, tolerability, and Pharmacokinetics/Pharmacodynamics of GC1113 after Single Intravenous/Subcutaneous Administration in Healthy Male Subjects.
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
- •Adult male subjects between 20 to 55 years of age
- •60kg ≤ weight ≤ 90kg, 19 ≤ BMI ≤ 27
- •12 g/dL ≤ Hemoglobin ≤ 16 g/dL within the 28 days prior to investigational product (IP)injection
- •WBC ≥ 3.0Ⅹ10^9/L, platelet ≥ 140Ⅹ10^9/L within the 28 days prior to IP injection
排除标准
- •Allergic to IP ingredients
- •History of uncontrolled liver, kidney, respiratory, endocrine, neurology, immunology, hematology, mental symptom, circulatory and malignancy disease
- •Prior exposure to EPO, darbepoetin, other EPO, immunoglobulin, IV iron supplementation
- •History of hypersensitivity reaction to EPO, darbepoetin, excipient of IP or hyperergia to iron supplementation
- •Epilepsy within the 6 months prior to IP injection
- •Positivity for HIV antibody, HBsAg, HCV antibody test
- •Spleen length > 16㎝
研究组 & 干预措施
Group A
GC1113 or Placebo: GC1113 0.3ug/kg to 5ug/kg once intravenously
干预措施: GC1113 (Drug)
Group B
GC1113 or Placebo: GC1113 0.3ug/kg to 5ug/kg once intravenously
干预措施: GC1113 (Drug)
Group C
GC1113 or Placebo: GC1113 0.3ug/kg to 5ug/kg once intravenously
干预措施: GC1113 (Drug)
Group D
GC1113 or Placebo: GC1113 0.3ug/kg to 5ug/kg once intravenously
干预措施: GC1113 (Drug)
Darbepoetin alfa 30ug/kg by IV
Darbepoetin alfa 30ug/kg once intravenously
干预措施: Darbepoetin alfa (Drug)
Group H
GC1113 or Placebo: GC1113 1ug/kg to 8ug/kg once subcutaneously
干预措施: GC1113 (Drug)
Group I
GC1113 or Placebo: GC1113 1ug/kg to 8ug/kg once subcutaneously
干预措施: GC1113 (Drug)
Group J
GC1113 or Placebo: GC1113 1ug/kg to 8ug/kg once subcutaneously
干预措施: GC1113 (Drug)
Group K
GC1113 or Placebo: GC1113 1ug/kg to 8ug/kg once subcutaneously
干预措施: GC1113 (Drug)
Darbepoetin alfa 30ug/kg by SC
Darbepoetin alfa 30ug/kg once subcutaneously
干预措施: Darbepoetin alfa (Drug)
结局指标
主要结局
Safety/ Tolerability Evaluation
时间窗: Up to 29 days after investigational product administration
Number of subjects with Adverse events, Physical examinations, Vital signs, electrocardiogram (ECG), Laboratory tests (including hematology, chemistry, coagulation, urinalysis)
次要结局
- AUClast of GC1113, Cmax of GC1113(Up to 29 days after investigational product administration)
- Immunogenicity of GC1113(Up to 29 days after investigational product administration)
- To compare safety and Pharmacokinetics/Pharmacodynamics with active control(Up to 29 days after investigational product administration)