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.
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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Masking
SINGLE
Enrollment
122
WCCT
Cypress, California, United States
Medpace CPU
Cincinnati, Ohio, United States
ICON
San Antonio, Texas, United States
Spaulding
West Bend, Wisconsin, United States
Bioequivalence as measured by PK and PD
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)
Time frame: 84 Days
PK Profile: Cmax
Characterization of the PK profile of CHS-1701 using standard parameters of maximum plasma concentration (Cmax)
Time frame: 84 Days
PK Profile: tmax
Characterization of the PK profile of CHS-1701 using standard parameters of time to maximum plasma concentration (tmax)
Time frame: 84 Days
PK Profile: AUC0-t
Characterization of the PK profile of CHS-1701 using standard parameters of area under the plasma concentration versus time curve calculated from 0 to the last measurable observation (AUC0-t)
Time frame: 84 Days
PK Profile: t1/2
Characterization of the PK profile of CHS-1701 using standard parameters of terminal elimination half-life (t1/2)
Time frame: 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)
Characterization of the safety profile and tolerance of CHS-1701, as assessed by clinical adverse events (AEs), laboratory variables, vital signs, incidence of antidrug antibodies (ADAs), and local injection site reactions (ISRs).
Time frame: 84 Days
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