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

Study Overview
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Brief Summary
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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

Detailed Description
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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

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 Korean 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: 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)

Ages Eligible for Study
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Minimum Age: 20 Years
Maximum Age: 55 Years

Sexes Eligible for Study
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Male

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: Cohort1<br> | Drug: HM10760A or Placebo<br>* 0.04 mcg/kg to 2.0mcg/kg once intravenously<br>|
| Experimental: Cohort2<br> | Drug: HM10760A or Placebo<br>* 0.04 mcg/kg to 2.0mcg/kg once intravenously<br>|
| Experimental: Cohort3<br> | Drug: HM10760A or Placebo<br>* 0.04 mcg/kg to 2.0mcg/kg once intravenously<br>|
| Experimental: Cohort4<br> | Drug: HM10760A or Placebo<br>* 0.04 mcg/kg to 2.0mcg/kg once intravenously<br>|
| Experimental: Cohort5<br> | Drug: HM10760A or Placebo<br>* 0.04 mcg/kg to 2.0mcg/kg once intravenously<br>|
| Experimental: Cohort6<br> | Drug: HM10760A or Placebo<br>* 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 immunogenicity |  | 84 days | 

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