To Evaluate the Safety, Tolerability, and Pharmacokinetics/Pharmacodynamics of Erythropoietin

A Dose-Block Randomized, Double-blind Placebo Controlled, Open-label Active Controlled, Dose-escalation Study to Investigate the Safety, Tolerability, and Pharmacokinetics/Pharmacodynamics of GC1113 After Single Intravenous/Subcutaneous Administration in Healthy Male Subjects

This is a Dose-Block Randomized, Double-blind Placebo controlled, Open-label Active controlled, Dose-escalation Study to investigate the safety, tolerability, and Pharmacokinetics/Pharmacodynamics of GC1113 after Single Intravenous/Subcutaneous Administration in Healthy Male Subjects.

Inclusion Criteria:

• Written informed consent
• Adult male subjects between 20 to 55 years of age
• 60kg ≤ weight ≤ 90kg, 19 ≤ BMI ≤ 27
• 12 g/dL ≤ Hemoglobin ≤ 16 g/dL within the 28 days prior to investigational product (IP)injection
• WBC ≥ 3.0Ⅹ10^9/L, platelet ≥ 140Ⅹ10^9/L within the 28 days prior to IP injection

Exclusion Criteria:

• Allergic to IP ingredients
• History of uncontrolled liver, kidney, respiratory, endocrine, neurology, immunology, hematology, mental symptom, circulatory and malignancy disease
• Prior exposure to EPO, darbepoetin, other EPO, immunoglobulin, IV iron supplementation
• History of hypersensitivity reaction to EPO, darbepoetin, excipient of IP or hyperergia to iron supplementation
• Epilepsy within the 6 months prior to IP injection
• Positivity for HIV antibody, HBsAg, HCV antibody test
• Spleen length > 16㎝