Pegfilgrastim biosimilar (PharmaEssentia)

The goal of this study type: PK clinical trial is to evaluate the safety, tolerability, and pharmacokinetics/ pharmacodynamics of PEG-MetHuG-CSF (P2203) in Healthy Volunteers.
Primary objective:
‧ To evaluate the safety and tolerability of P2203
Secondary objectives:
‧ To characterize the pharmacokinetics (PK), pharmacodynamics (PD), and immunogenicity of P2203
Approximately 30 healthy volunteers will be enrolled. Subjects will be screened within 28 days before study dosing. Eligible subjects will be sequentially enrolled into 2 escalating-dose cohorts (Cohort 1 and 2) to receive a single dose of P2203 at a pre-determined specific dose or to re-ceive a single dose of 6 mg pegfilgrastim (Neulasta).