A Randomized, Single-Blind, Crossover Study to Assess the Pharmacokinetic and Pharmacodynamic Bioequivalence 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
- 122
- 试验地点
- 4
- 主要终点
- Bioequivalence as measured by PK and PD
研究概览
简要总结
This is a randomized, single-blind, 3-period crossover study in healthy subjects to assess PK, PD, and safety (including immunogenicity) of a single 6mg subcutaneous injection of CHS-1701 (Coherus pegfligrastim) or 6mg SC dose of Neulasta (pegfilgrastim) given during each period.
详细描述
This is a randomized, single-blind, 3-period crossover study in healthy subjects to assess PK, PD, and safety (including immunogenicity) of a single 6mg subcutaneous injection of CHS-1701 or 6mg SC dose of Neulasta given during each period.
The screening period may occur up to 28 days prior to the confinement period. After screening, eligible subjects will be randomly assigned to one of three possible treatment sequences. Treatments will be spaced by not less than 28 days.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 盲法
- Single (Participant)
入排标准
- 年龄范围
- 18 Years 至 45 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 45 inclusive
- •Body weight > 50 kg (110 lb.) and body mass index between 18 and 28 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
- •Current or previous cancer, diabetes, or any clinically significant cardiovascular, metabolic, endocrine, renal, hepatic, gastrointestinal, hematologic, respiratory, dermatological, neurological, gynecologic, psychiatric, or other disorder
- •History of chronic or acute respiratory illness within the past 3 months
- •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
- •History of known clinically significant drug and/or food allergies, including allergic reaction to latex
研究组 & 干预措施
Sequence A
3 doses of CHS-1701 or Neulasta, random order
干预措施: CHS-1701 (Drug)
Sequence A
3 doses of CHS-1701 or Neulasta, random order
干预措施: Pegfilgrastim (Drug)
Sequence B
3 doses of CHS-1701 or Neulasta, random order
干预措施: CHS-1701 (Drug)
Sequence B
3 doses of CHS-1701 or Neulasta, random order
干预措施: Pegfilgrastim (Drug)
Sequence C
3 doses of CHS-1701 or Neulasta, random order
干预措施: CHS-1701 (Drug)
Sequence C
3 doses of CHS-1701 or Neulasta, random order
干预措施: Pegfilgrastim (Drug)
结局指标
主要结局
Bioequivalence as measured by PK and PD
时间窗: 84 Days
The primary objective of this study is to assess the bioequivalence 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: t1/2(84 Days)
- PK Profile: Cmax(84 Days)
- PK Profile: AUC0-t(84 Days)
- PK Profile: tmax(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)