A Study of HM10760A (Long-acting Erythropoietin (EPO)) in Healthy Korean Subjects
NCT ID: NCT01013064
Last Updated: 2014-02-07
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE1
48 participants
INTERVENTIONAL
2009-11-30
2011-01-31
Brief Summary
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* 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
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Detailed Description
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* 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
Conditions
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Study Design
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RANDOMIZED
SINGLE_GROUP
TREATMENT
TRIPLE
Study Groups
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Cohort1
HM10760A or Placebo
0.04 mcg/kg to 2.0mcg/kg once intravenously
Cohort2
HM10760A or Placebo
0.04 mcg/kg to 2.0mcg/kg once intravenously
Cohort3
HM10760A or Placebo
0.04 mcg/kg to 2.0mcg/kg once intravenously
Cohort4
HM10760A or Placebo
0.04 mcg/kg to 2.0mcg/kg once intravenously
Cohort5
HM10760A or Placebo
0.04 mcg/kg to 2.0mcg/kg once intravenously
Cohort6
HM10760A or Placebo
0.04 mcg/kg to 2.0mcg/kg once intravenously
Interventions
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HM10760A or Placebo
0.04 mcg/kg to 2.0mcg/kg once intravenously
Eligibility Criteria
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Inclusion Criteria
* Able and willing to provided written informed consent
* Hemoglobin \< 16 g/dL
Exclusion Criteria
* 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)
20 Years
55 Years
MALE
Yes
Sponsors
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Hanmi Pharmaceutical Company Limited
INDUSTRY
Responsible Party
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Locations
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Hanmi Clinical
Seoul, , South Korea
Countries
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Other Identifiers
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09-HM10760A-102
Identifier Type: -
Identifier Source: org_study_id
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