This is a phase 1, single-center, randomized, double-blind, two-way crossover study employing Abcertin and EU-sourced Cerezyme in healthy volunteers between the ages of 18 and 45 years (inclusive). The study aimed to evaluate the PK, safety, tolerability and immunogenicity of Abcertin compared with EU-sourced Cerezyme when administered as a single dose.
Primary Objective:~To compare the pharmacokinetics of Abcertin to the reference product, EU-sourced Cerezyme, after single intravenous administration of 60 IU/kg.~Secondary Objective:~To compare the safety, tolerability and immunogenicity of Abcertin to the reference formulation, EU-sourced Cerezyme, after single intravenous administration of 60 IU/kg.