NCT02912377已完成1 期
Multiple-doses, Randomised, Double-blind, Three-periods, Two-sequences Crossover Study to Assess the Immunogenicity and Pharmacodynamic Comparability of a Biosimilar Pegfilgrastim (B12019) and the Reference Product Neulasta® in Healthy Subjects
Cinfa Biotech2 个研究点 分布在 1 个国家目标入组 96 人开始时间: 2016年9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
- 96
- 试验地点
- 2
- 主要终点
- Incidence of anti-drug antibodies (ADAs)
研究概览
简要总结
Multiple-doses, randomised, double-blind, three-periods, two-sequences crossover study to assess the immunogenicity and pharmacodynamic comparability of a biosimilar pegfilgrastim (B12019) and the reference product Neulasta® in healthy subjects
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, between 18 and 55 years of age (inclusive).
- •BMI between 20.0 and 30.0 kg/m² (inclusive).
- •Weight between 60 and 100 kg (inclusive).
- •Non-smoker for at least 3 months or mild smokers with a consumption of less than 5 cigarettes (or equivalent) per day prior to study start.
- •Healthy subjects as determined by medical history, physical examination including vital signs, ECG and clinical laboratory testing.
- •Able to comply with protocol requirements, including overnight stays, blood sample collections as defined in the protocol and to participate in the entire trial period.
- •Subjects who are able and willing to give written informed consent.
- •Male subject and his female spouse/partner who is of childbearing potential must be using effective contraception starting at screening and continue throughout the clinical study period.
- •Male subject must not donate sperm starting at screening and throughout the clinical study period and for 3 months after final study drug administration.
排除标准
- •History of:
- •Evidence in the subject's medical history or in the medical examination of any clinically significant hepatic, renal, gastrointestinal, cardiovascular, pulmonary, haematological, central nervous system diseases or other significant acute or chronic diseases, especially hereditary fructose intolerance, which might influence either the safety of the subject or the absorption, metabolism or excretion of the active agent under investigation.
- •Subjects with clinically relevant neurologic or psychiatric illness.
- •Subjects with clinically relevant allergy (except for untreated, asymptomatic, seasonal allergies at time of dosing).
- •Previous exposure to pegfilgrastim.
- •Known hypersensitivity to Escherichia coli-derived proteins, pegfilgrastim, filgrastim or any other component of B12019 or Neulasta® as listed in section 7.
- •History of allergy to any recombinant protein.
- •History of cancer.
- •History of haematological disease, including sickle cell disorder.
- •History of pulmonary infiltrates or pneumonia within 6 months before the first study drug administration.
- •Known anti-drug antibodies to filgrastim or pegfilgrastim, including known antibodies to PEG as a consequence of exposure to PEG other than pegfilgrastim (e.g. cosmetics, etc.).
- •Subjects not willing or able to comply with the food and beverage restrictions (grapefruit/pomelo, starfruit, poppy seeds).
结局指标
主要结局
Incidence of anti-drug antibodies (ADAs)
时间窗: 6 weeks
Incidence of anti-drug antibodies over time (ADAs)
Absolute Neutrophil count (ANC)
时间窗: 6 weeks
AUEC0-last of ANC
次要结局
未报告次要终点
研究者
研究点 (2)
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