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

Gaucher Disease Clinical Trial

Official title:
A Randomized, Double-blind, 2-treatment, 2-period, Crossover Phase I Study to Compare the PK, Safety and Tolerability of 60 IU/kg of Abcertin, and EU-sourced Cerezyme® in Healthy Volunteers Following a Single Intravenous Administration

Clinical Trial 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.

Clinical Trial Description

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. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT04787887
Study type Interventional
Source ISU Abxis Co., Ltd.
Contact
Status Completed
Phase Phase 1
Start date January 29, 2020
Completion date October 26, 2020
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