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

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ClinicalTrials.gov Identifier: NCT01013064
Recruitment Status : Completed
First Posted : November 13, 2009
Last Update Posted : February 7, 2014
Sponsor:
Information provided by (Responsible Party):
Hanmi Pharmaceutical Company Limited

Brief Summary:

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

Condition or disease Intervention/treatment Phase
Healthy Drug: HM10760A or Placebo Phase 1

Detailed Description:

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

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 48 participants
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Treatment
Official Title: 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
Study Start Date : November 2009
Actual Primary Completion Date : December 2010
Actual Study Completion Date : January 2011

Arm Intervention/treatment
Experimental: Cohort1 Drug: HM10760A or Placebo
0.04 mcg/kg to 2.0mcg/kg once intravenously
Experimental: Cohort2 Drug: HM10760A or Placebo
0.04 mcg/kg to 2.0mcg/kg once intravenously
Experimental: Cohort3 Drug: HM10760A or Placebo
0.04 mcg/kg to 2.0mcg/kg once intravenously
Experimental: Cohort4 Drug: HM10760A or Placebo
0.04 mcg/kg to 2.0mcg/kg once intravenously
Experimental: Cohort5 Drug: HM10760A or Placebo
0.04 mcg/kg to 2.0mcg/kg once intravenously
Experimental: Cohort6 Drug: HM10760A or Placebo
0.04 mcg/kg to 2.0mcg/kg once intravenously



Primary Outcome Measures :
  1. Safety data, including physical examinations, laboratory evaluation, ECGs, vital signs, adverse events, and immunogenicity [ Time Frame: 84 days ]


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Ages Eligible for Study:   20 Years to 55 Years   (Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes
Criteria

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)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01013064


Locations
Korea, Republic of
Hanmi Clinical
Seoul, Korea, Republic of
Sponsors and Collaborators
Hanmi Pharmaceutical Company Limited

Responsible Party: Hanmi Pharmaceutical Company Limited
ClinicalTrials.gov Identifier: NCT01013064     History of Changes
Other Study ID Numbers: 09-HM10760A-102
First Posted: November 13, 2009    Key Record Dates
Last Update Posted: February 7, 2014
Last Verified: February 2014

Keywords provided by Hanmi Pharmaceutical Company Limited:
Erythropoietin
Long acting
EPO

Additional relevant MeSH terms:
Epoetin Alfa
Hematinics