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

Authors
Category Primary study
Registry of Trialsclinicaltrials.gov
Year 2020
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.
Epistemonikos ID: 0b2ccdbfb262734d95d9cccbd06d7c24ae2b2429
First added on: May 08, 2024