Ignite Creation Date:
2024-05-06 @ 3:51 PM
Last Modification Date:
2024-10-26 @ 1:58 PM
Study NCT ID:
NCT04787887
Status:
COMPLETED
Last Update Posted:
2021-04-05
First Post:
2021-03-04
Brief Title:
A Phase I Study to Compare Abcertin and EU-sourced Cerezyme in Healthy Volunteers
Sponsor:
ISU Abxis Co Ltd
Organization:
ISU Abxis Co Ltd
Study Overview
Official Title:
A Randomized Double-blind 2-treatment 2-period Crossover Phase I Study to Compare the PK Safety and Tolerability of 60 IUkg of Abcertin and EU-sourced Cerezyme in Healthy Volunteers Following a Single Intravenous Administration
Status:
COMPLETED
Status Verified Date:
2021-04
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
Primary Objective
To compare the pharmacokinetics of Abcertin to the reference product EU-sourced Cerezyme after single intravenous administration of 60 IUkg
Secondary Objective
To compare the safety tolerability and immunogenicity of Abcertin to the reference formulation EU-sourced Cerezyme after single intravenous administration of 60 IUkg
To compare the pharmacokinetics of Abcertin to the reference product EU-sourced Cerezyme after single intravenous administration of 60 IUkg
Secondary Objective
To compare the safety tolerability and immunogenicity of Abcertin to the reference formulation EU-sourced Cerezyme after single intravenous administration of 60 IUkg
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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| ACTRN12619001399189p | REGISTRY | ANZCTR | None |