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

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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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

Conditions
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Healthy

Intervention / Treatment
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* Drug: HM10760A or placebo


Participation Criteria
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Eligibility Criteria
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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)

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 55 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Cohort 1<br>The lowest dose level of HM10760A | Drug: HM10760A or placebo<br>* Once, 0.04 mcg/kg to 2.0mcg/kg once intravenously<br>|
| Experimental: Cohort 2<br>Second dose level of HM10760A | Drug: HM10760A or placebo<br>* Once, 0.04 mcg/kg to 2.0mcg/kg once intravenously<br>|
| Experimental: Cohort 3<br>Third dose level of HM10760A | Drug: HM10760A or placebo<br>* Once, 0.04 mcg/kg to 2.0mcg/kg once intravenously<br>|
| Experimental: Cohort 4<br>Fourth dose level of HM10760A | Drug: HM10760A or placebo<br>* Once, 0.04 mcg/kg to 2.0mcg/kg once intravenously<br>|
| Experimental: Cohort 5<br>The highest dose level of HM10760A | Drug: HM10760A or placebo<br>* Once, 0.04 mcg/kg to 2.0mcg/kg once intravenously<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Safety data, including physical examinations, laboratory evaluation, ECGs, vital signs, adverse events, and endogenous erythropoietin level. |  | 84 days after the investigational drug administration. | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Erythropoietin, Long-acting, EPO