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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01013064
First Posted: November 13, 2009
Last Update Posted: February 7, 2014
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Hanmi Pharmaceutical Company Limited
  Purpose

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 Intervention Phase
Healthy Drug: HM10760A or Placebo Phase 1

Study Type: Interventional
Study Design: 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

Further study details as provided by Hanmi Pharmaceutical Company Limited:

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

Enrollment: 48
Study Start Date: November 2009
Study Completion Date: January 2011
Primary Completion Date: December 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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
  Eligibility

Information from the National Library of Medicine

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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)
  Contacts and Locations
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
  More Information

Responsible Party: Hanmi Pharmaceutical Company Limited
ClinicalTrials.gov Identifier: NCT01013064     History of Changes
Other Study ID Numbers: 09-HM10760A-102
First Submitted: November 10, 2009
First Posted: November 13, 2009
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