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
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 Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
40
Single-intravenous administration
Hanyang University Medical Center
Seoul, South Korea
PharmacoKinetic parameters (Cmax)
To measure the concentration of Efepoetin alfa in serum for 336 hours after administration of the investigational product for the pharmacokinetic parameters peak blood concentration
Time frame: up to 4 weeks
PharmacoKinetic parameters (AUClast)
To measure the concentration of Efepoetin alfa in serum for 336 hours after administration of the investigational product for the pharmacokinetic parameters area under the blood concentration-time curve
Time frame: up to 4 weeks
PharmacoKinetic parameters (AUC0-t, AUCinf, AUC%Extrap, CL, tmax, Vd, t1/2)
Pharmacokinetic parameters of Efepoetin alfa blood concentration after a single intravenous administration of the investigational product
Time frame: up to 4 weeks
Pharmacodynamic parameters (Emax, ΔEmax, AUEC, ΔAUEC)
Pharmacodynamic parameters of hemoglobin, reticulocyte and reticulocyte hemoglobin content after administration of the investigational product
Time frame: up to 4 weeks
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