NCT04787887

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

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

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 42 (actual)
• Sponsor: ISU Abxis Co., Ltd. · Industry
• Sex: All
• Age: 18 Years – 45 Years
• Healthy volunteers: Accepted

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.

Detailed 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.

Conditions

• Gaucher Disease

Interventions

Type	Name	Description
DRUG	Abcertin	60IU/kg Single Intravenous Administration
DRUG	EU-sourced Cerezyme	60IU/kg Single Intravenous Administration

Timeline

• Start date: 2020-01-29
• Primary completion: 2020-09-27
• Completion: 2020-10-26
• First posted: 2021-03-09
• Last updated: 2021-04-05

Locations

1 site across 1 country: Australia