NCT02629562已完成1 期
Single-dose, Randomised, Double-blind, Two-stage, Two-way Crossover Pharmacokinetic and Pharmacodynamic Evaluation of a Biosimilar Pegfilgrastim (B12019) Versus the Reference Product Neulasta® in Healthy Subjects
Cinfa Biotech2 个研究点 分布在 1 个国家目标入组 172 人开始时间: 2015年11月1日最近更新:
适应症
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- 入组人数
- 172
- 试验地点
- 2
- 主要终点
- PD parameter ANC
研究概览
简要总结
Multi-centre, double-blind, randomised, 2-way cross-over study to investigate the PK and PD of B12019 as compared to Neulasta® administered as a single subcutaneous (s.c.) dose in healthy male subjects. B12019 or Neulasta will be administered by s.c. injection.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- Triple (Participant, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 55 Years（Adult）
- 性别
- Male
- 接受健康志愿者
- 是
入选标准
- •Healthy male subjects
- •Age ≥18 and ≤55 years
- •BMI 22.0 - 28.0 kg/m2
- •Non-smokers for at least 6 months prior to study start
- •General good health, based on a comprehensive medical history and physical examination
- •Adequate organ function and normal laboratory values (unless the investigator considers an abnormality to be clinically not relevant)
- •Negative hepatitis B surface antigen (HBsAg), hepatitis C antibody and human immunodeficiency virus (HIV) tests at screening
- •Signed informed consent
排除标准
- •Known hypersensitivity to Escherichia coli derived proteins, pegfilgrastim, filgrastim or any other component of B12019 or Neulasta®
- •Previous exposure to filgrastim or pegfilgrastim
- •History of drug or alcohol abuse
- •Blood donations in the past 3 months prior to study start, or bone marrow or stem cell donor in the past 12 months (first dose)
- •Medical history of haematological disease, including sickle cell disorders
- •Recent infection (within 1 week prior to first dose)
- •Relevant history of renal, hepatic, gastrointestinal, cardiovascular, respiratory, skin, haematological, endocrine, inflammatory or neurological diseases, that in the opinion of the investigator may interfere with the aim of the study
- •Participation in an interventional or Phase I study in the last 3 months or is current a follow-up visit schedule for any study, or has participation in more than three studies of experimental drug products in the past 12 months prior to screening
- •Subjects with ANC values outside the normal laboratory range at screening
- •Use of prescription or over-the-counter drugs including vitamins within 4 weeks of first dosing
- •Abnormalities in ECG
- •Signs of dermatitis or skin abnormalities affecting the administration area and surroundings
- •History of cancer
结局指标
主要结局
PD parameter ANC
时间窗: 6 weeks
AUEC0-last
PK parameter AUC0-last
时间窗: 6 weeks
Area under the plasma concentration-time curve
PK parameter Cmax
时间窗: 6 weeks
Maximum observed drug concentration
次要结局
未报告次要终点
研究者
研究点 (2)
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