A Study of HM10760A (Long-acting Erythropoietin (EPO)) in Healthy Korean Subjects

A Randomized, Double-blind, Placebo-controlled, Sequential Dose Escalation Study of the Safety, Pharmacodynamics and Pharmacokinetics of Single Intravenous Doses of HM10760A in Healthy Adult Korean Subjects

Study design:

• Randomized, double-blind, placebo-controlled, sequential dose escalation
• Six ascending dose cohorts are planned

Primary Objective:

• To evaluate the safety profile of single escalating intravenous dose levels of HM10760A

Secondary objectives:

• To evaluate the dose response relationship of a single IV dose of HM10760A on pharmacodynamic parameters including hemoglobin, reticulocyte count, and reticulocyte hemoglobin content
• To evaluate the pharmacokinetic profiles of single IV dose levels of HM10760A
• To determine the pharmacologically active dose(PAD) of HM10760A
• To assess the immunogenicity of a single IV dose of HM10760A

Inclusion Criteria:

• Age 20 to 55 years
• Able and willing to provided written informed consent
• Hemoglobin < 16 g/dL

Exclusion Criteria:

• Prior exposure to EPO, darbepoetin, other EPO support proteins
• hypersensitivity to EPO, darbepoetin, E.coli derived proteins
• Hemoglobinopathy
• SBP > 140 mmHg or < 90 mmHg or DBP > 95 mmHg
• Chronic, uncontrolled, or symptomatic inflammatory disease
• Malignancy(except non-melanoma skin cancer)