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

NCT04787887 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 42

Last updated 2021-04-05

No results posted yet for this study

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.

Conditions

  • Gaucher Disease

Interventions

DRUG

Abcertin

60IU/kg Single Intravenous Administration

DRUG

EU-sourced Cerezyme

60IU/kg Single Intravenous Administration

Sponsors & Collaborators

  • ISU Abxis Co., Ltd.

    lead INDUSTRY

Principal Investigators

  • Charlotte Lemech, MD · Scientia Clinical Research Limited

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Max Age
45 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2020-01-29
Primary Completion
2020-09-27
Completion
2020-10-26

Countries

  • Australia

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04787887 on ClinicalTrials.gov