This is a randomized, placebo controlled, single dose study to assess the safety, tolerability, pharmacokinetics and pharmacodynamics of GX-E2 in healthy male subjects.
The purpose of this study is to investigate the safety, tolerability and pharmacokinetics of GX-E2 when given as single dose (GX-E2 8 ug/kg) to healthy male subjects. Additionally, Immunogenecity will be evaluated to investigate antibody production.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
10
Seoul National University Hospital
Seoul, South Korea
pharmacokinetics as measured by Cmax
Measures "Cmax, AUC(0-tlast), AUCing, Tmax, t1/2 and CL/F after single dose of 8ug/kg GX-E2"
Time frame: Day1 - 29
pharmacokinetics as measured by Cmax AUC(0-tlast)
Measures "Cmax, AUC(0-tlast), AUCing, Tmax, t1/2 and CL/F after single dose of 8ug/kg GX-E2"
Time frame: Day1 - 29
pharmacokinetics as measured by AUCing
Measures "Cmax, AUC(0-tlast), AUCing, Tmax, t1/2 and CL/F after single dose of 8ug/kg GX-E2"
Time frame: Day1 - 29
pharmacokinetics as measured by Tmax
Measures "Cmax, AUC(0-tlast), AUCing, Tmax, t1/2 and CL/F after single dose of 8ug/kg GX-E2"
Time frame: Day1 - 29
pharmacokinetics as measured by t1/2
Measures "Cmax, AUC(0-tlast), AUCing, Tmax, t1/2 and CL/F after single dose of 8ug/kg GX-E2"
Time frame: Day1 - 29
pharmacokinetics as measured by CL/F
Measures "Cmax, AUC(0-tlast), AUCing, Tmax, t1/2 and CL/F after single dose of 8ug/kg GX-E2"
Time frame: Day1 - 29
pharmacodynamics as measured by Hemoglobin
Hemoglobin, Reticulocyte count, Reticulocyte hemoglobin contents
Time frame: Day1 - 29
pharmacodynamics as measured by Reticulocyte count
Time frame: Day1 - 29
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pharmacodynamics as measured by Reticulocyte hemoglobin contents
Time frame: Day1 - 29
Safety and Tolerability of GX-E2 as checked immunogenecity
Time frame: Day1 - 29