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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Hanmi Pharmaceutical Company Limited
ClinicalTrials.gov Identifier:
NCT01013064
First received: November 10, 2009
Last updated: February 6, 2014
Last verified: February 2014
  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
Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: Double Blind (Subject, Caregiver, 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 ] [ Designated as safety issue: Yes ]

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

Ages Eligible for Study:   20 Years to 55 Years
Genders 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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01013064

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

No publications provided

Responsible Party: Hanmi Pharmaceutical Company Limited
ClinicalTrials.gov Identifier: NCT01013064     History of Changes
Other Study ID Numbers: 09-HM10760A-102
Study First Received: November 10, 2009
Last Updated: February 6, 2014
Health Authority: Korea: Food and Drug Administration

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

ClinicalTrials.gov processed this record on October 16, 2014