Bioequivalence Clinical Trial
Official title:
A Randomized, Double-Blind, Crossover Study to Compare the Pharmacokinetic and Pharmacodynamic Biosimilarity of CHS-1701 (Coherus Pegfilgrastim) With Neulasta® in Healthy Subjects
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®.
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.
;
Allocation: Randomized, Endpoint Classification: Bio-equivalence Study, Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Caregiver, Investigator)
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