A Phase I Study to Compare Abcertin and EU-sourced Cerezyme® in Healthy Volunteers

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.

Timeline

Start

2020-01-29

Primary completion

2020-09-27

Completion

2020-10-26

Drugs

Indications