A Study of HM10760A (Long-acting Erythropoietin) in Healthy Adult Caucasian and Japanese 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 Caucasian and Japanese Subjects

Study design:

• Phase I, first-in-human, randomized, double-blind, placebo-controlled, sequential dose escalation study of intravenously administered HM10760A in healthy adult Caucasian and Japanese subjects. Up to 5 dose level cohorts are planned. In each dose level cohort, subjects will be randomized to receive a single dose of HM10760A or placebo.

Primary Objective:

• To evaluate safety profile of single intravenous (IV) dose levels of HM10760A in healthy adult Caucasian and Japanese subjects.

Secondary Objectives:

• To evaluate the dose response relationship of a single IV dose of HM10760A on pharmacodynamic parameters
• To assess the immunogenicity of a single IV dose of HM10760A.

Inclusion Criteria:

• Healthy Caucasian and Japanese male and/or female volunteers
• Age 18 to 55 years
• Hemoglobin of >12 g/dL and <16 g/dL for male subjects, >10 g/dL and <14 g/dL for female Caucasian subjects

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)