Clinical Trial 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.

Key Inclusion Criteria:

• Adult males and females between the ages of 19-45
• Asian or Caucasian
• Body weight >50 kg and <90 kg, BMI 18 ~30 (BMI(kg/m2) = Weight(kg) / {Height(m)}2)
• Normal hemoglobin range.
• Normal Serum ferritin and transferrin saturation range.
• Normal serum folate range
• Normal vitamin B12 range
• White blood cell >=3.0 X 10^3 /mm3
• Platelet >= 150 X 10^3/mm^3 and <450 X 10^3/mm^3
• Nonsmoker or smoker who smokes below 10 cigarettes a day.

Key Exclusion Criteria:

• An allergy history, including drug allergies(example: aspirin, antibiotics, etc.) or clinically significant allergy.
• Liver(including viral hepatitis), renal, respiratory, endocrine, neurological, immunological, blood, psychological, or circulatory system abnormalities, or a history of cancer.
• Subject who had received EPO, darbepoetin, other EPO supply protein, or immunoglobulin administration, or had received intravenous iron administration.
• Hypersensitivity to EPO and/or to the excipients of the IMP, or known hypersensitivity to supplementary iron products.
• Hemoglobinopathy (homozygous sickle cell disease, all types of thalassemia)
• Systolic blood pressure below 90mmHg or above 140mmHg, or diastolic blood pressure below 50mmHg or above 90mmHg after taking a rest over 3 minutes; pulse rate over 100bpm
• C-reactive protein level >4mg/dL at 2 weeks prior to the IMP administration.
• A drug abuse history, or positive in a urine drug-screening test(cocaine, amphetamines, barbiturates, opiates, benzodiazepine, and cannabinoids)
• Signs of fever, with a temperature of over 38°C, within 1 week before particiation
• History of epileptic seizure within 6 months before participation
• Positive to HIV antibody, HBsAg, and HCV antibody test.
• Consumes over 21 units of alcohol per week, or a person who cannot stay sober for the duration of the entire trial period.
• Blood donation or a bleeding episode of more than 400mL within 8 weeks prior to study participation
• The maximum length of the spleen >16cm.
• Person thought inappropriate by the investigator in consideration of the laboratory test results.
• Pregnant or breast-feeding.