Ignite Creation Date:
2024-07-17 @ 12:01 PM
Last Modification Date:
2024-10-26 @ 3:34 PM
Study NCT ID:
NCT06490939
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-07-09
First Post:
2024-07-01
Brief Title:
Clinical Trial of Efepoetin Alfa in Healthy Subjects
Sponsor:
Genexine Inc
Organization:
Genexine Inc
Study Overview
Official Title:
An Open-label Parallel-group Single-center Phase I Study to Compare the PharmacokineticPharmacodynamic Characteristics Safety and Tolerability of a Single Intravenous Administration of Efepoetin Alfa in Healthy Caucasian and Asian Volunteers
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-07
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:
An open-label parallel-group single-center Phase I study to compare the pharmacokineticpharmacodynamic characteristics safety and tolerability of a single intravenous administration of Efepoetin Alfa in healthy subjects
Detailed Description:
This study is to objectively evaluate pharmacokinetics as well as pharmacodynamic responses after a single intravenous administration of the Efepoetin alfa GX-E4 in healthy Caucasian and Asian volunteers
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