A Phase I Study to Compare Abcertin and EU-sourced Cerezyme® in Healthy Volunteers
Status:
Completed
Trial end date:
2020-10-26
Target enrollment:
Participant gender:
Summary
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.