NCT06490939

Clinical Trial of Efepoetin Alfa in Healthy Subjects

An Open-label, Parallel-group, Single-center, Phase I Study to Compare the Pharmacokinetic/Pharmacodynamic Characteristics, Safety, and Tolerability of a Single Intravenous Administration of Efepoetin Alfa in Healthy Caucasian and Asian Volunteers

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 40 (actual)
• Sponsor: Genexine, Inc. · Industry
• Sex: All
• Age: 19 Years – 45 Years
• Healthy volunteers: Accepted

Summary

An open-label, parallel-group, single-center, Phase I study to compare the pharmacokinetic/pharmacodynamic 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.

Conditions

• Healthy

Interventions

Type	Name	Description
DRUG	Efepoetin Alfa	Single-intravenous administration

Timeline

• Start date: 2024-10-29
• Primary completion: 2025-03-25
• Completion: 2025-03-25
• First posted: 2024-07-08
• Last updated: 2025-08-21

Locations

1 site across 1 country: South Korea