A Randomized, Double-Blind, Crossover Study to Compare the Pharmacokinetic and Pharmacodynamic Biosimilarity of CHS-1701 (Coherus Pegfilgrastim) With Neulasta® in Healthy Subjects
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 116
- 试验地点
- 1
- 主要终点
- Biosimilarity as measured by absolute neutrophil count (ANC)
研究概览
简要总结
This is a randomized, double-blind, single-dose, 2-period crossover study in healthy subjects to assess PK, PD, and safety (including immunogenicity) of a single 6 mg subcutaneous (SC) injection of CHS-1701 compared with a single 6 mg SC dose of Neulasta®.
详细描述
This is a randomized, double-blind, single-dose, 2-period crossover study in healthy subjects to assess PK, PD, and safety (including immunogenicity) of a single 6 mg subcutaneous (SC) injection of CHS-1701 compared with a single 6 mg SC dose of Neulasta®.
After screening, eligible subjects will be randomly assigned to 1 of 2 treatment sequences; CHS-1701 followed by Neulasta® (Sequence A) or Neulasta® followed by CHS-1701, Sequence B). Treatments will be spaced by a minimum of 6 weeks apart (but no more than 8 weeks). Subjects will be admitted to the Clinical Pharmacology Unit (CPU) on Day -1 (Period 1) and will be confined through Hour 96 postdose (a total of approximately 4.5 days and 5 nights). Blood samples will be collected at specified time points postdose for plasma PK and PD measurements and the subjects will be closely monitored for safety. Following discharge on the morning of Day 5 (Period 1) subjects will return to the clinic for additional PK, PD and safety follow up--daily through Day 9 and at stated interval time points thereafter.
The single dose of the alternate blinded study drug will be given after 6 (but no more than 8) weeks of observation and washout and the above procedures will be repeated (Period 2). A Follow up Visit will take place 41 (±1) days after the second dose.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 盲法
- Triple (Participant, Care Provider, Investigator)
入排标准
- 年龄范围
- 18 Years 至 50 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Adult male or female of ages 18 to 50 inclusive
- •Body weight > 50 kg (110 lb.) and body mass index between 18 and 32 kg/m2 inclusive
- •Medically healthy with clinically insignificant findings based on medical history, 12-lead ECG, and physical examination
- •Negative urine pregnancy test in women of childbearing potential
排除标准
- •Previous exposure to pegfilgrastim or filgrastim, or known allergy to PEG (polyethylene glycol)
- •Chemistry and hematology values outside protocol specified range
- •Current or previous cancer, diabetes, or any clinically significant cardiovascular, metabolic, renal, hepatic, gastrointestinal, hematologic, respiratory, dermatological, neurological, psychiatric, or other disorder
- •History of chronic or acute respiratory illness within the past 4 weeks
- •Positive urine drug or alcohol screen or unwillingness to abstain from alcohol or recreational drugs for the duration of study participation
- •No prescription or nonprescription drugs during the study
- •Participation in an investigational clinical study within 30 days prior to screening
- •Known or suspected allergic reaction to latex
研究组 & 干预措施
CHS-1701/Neulasta
CHS-1701 followed by Neulasta (crossover)
干预措施: CHS-1701 (Drug)
CHS-1701/Neulasta
CHS-1701 followed by Neulasta (crossover)
干预措施: Pegfilgrastim (Drug)
Neulasta/CHS-1701
Neulasta followed by CHS-1701 (crossover)
干预措施: CHS-1701 (Drug)
Neulasta/CHS-1701
Neulasta followed by CHS-1701 (crossover)
干预措施: Pegfilgrastim (Drug)
结局指标
主要结局
Biosimilarity as measured by absolute neutrophil count (ANC)
时间窗: 84 Days
The primary objective of this study is to assess the biosimilarity of CHS-1701 with Neulasta® based on the pharmacokinetics (PK) of pegfilgrastim and the pharmacodynamic (PD) response as measured by absolute neutrophil count (ANC).
次要结局
- PK Profile: Cmax (tmax), AUC0-t, and t1/2(84 Days)
- Safety Profile as assessed by clinical adverse events (AEs), laboratory variables, vital signs, incidence of antidrug antibodies (ADAs), and local injection site reactions (ISRs).(84 Days)