A Study of HM10760A (Long-acting Erythropoietin) in Healthy Adult Caucasian and Japanese Subjects
NCT ID: NCT01030315
Last Updated: 2014-02-26
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
65 participants
INTERVENTIONAL
2009-10-31
2011-01-31
Brief Summary
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* 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.
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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
* 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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Cohort 1
The lowest dose level of HM10760A
HM10760A or placebo
Once, 0.04 mcg/kg to 2.0mcg/kg once intravenously
Cohort 2
Second dose level of HM10760A
HM10760A or placebo
Once, 0.04 mcg/kg to 2.0mcg/kg once intravenously
Cohort 3
Third dose level of HM10760A
HM10760A or placebo
Once, 0.04 mcg/kg to 2.0mcg/kg once intravenously
Cohort 4
Fourth dose level of HM10760A
HM10760A or placebo
Once, 0.04 mcg/kg to 2.0mcg/kg once intravenously
Cohort 5
The highest dose level of HM10760A
HM10760A or placebo
Once, 0.04 mcg/kg to 2.0mcg/kg once intravenously
Interventions
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HM10760A or placebo
Once, 0.04 mcg/kg to 2.0mcg/kg once intravenously
Eligibility Criteria
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Inclusion Criteria
* 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
* 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)
18 Years
55 Years
ALL
Yes
Sponsors
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Hanmi Pharmaceutical Company Limited
INDUSTRY
Responsible Party
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Locations
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Hanmi Clinical
US, California, United States
Countries
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Other Identifiers
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09-HM10760A-101
Identifier Type: -
Identifier Source: org_study_id
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