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A Study of HM10760A (Long-acting Erythropoietin) in Healthy Adult Caucasian and Japanese Subjects (EPO)

This study has been completed.
Sponsor:
Information provided by:
Hanmi Pharmaceutical Company Limited
ClinicalTrials.gov Identifier:
NCT01030315
First received: December 10, 2009
Last updated: April 26, 2011
Last verified: April 2011
History of Changes
  Purpose

Study design:

  • 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.

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 Caucasian and Japanese Subjects

Resource links provided by NLM:

U.S. FDA Resources

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 endogenous erythropoietin level. [ Time Frame: 84 days after the investigational drug administration. ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 65
Study Start Date: October 2009
Study Completion Date: January 2011
Primary Completion Date: December 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Cohort 1
The lowest dose level of HM10760A
 Drug: HM10760A or placebo
Once, 0.04 mcg/kg to 2.0mcg/kg once intravenously
Experimental: Cohort 2
Second dose level of HM10760A
 Drug: HM10760A or placebo
Once, 0.04 mcg/kg to 2.0mcg/kg once intravenously
Experimental: Cohort 3
Third dose level of HM10760A
 Drug: HM10760A or placebo
Once, 0.04 mcg/kg to 2.0mcg/kg once intravenously
Experimental: Cohort 4
Fourth dose level of HM10760A
 Drug: HM10760A or placebo
Once, 0.04 mcg/kg to 2.0mcg/kg once intravenously
Experimental: Cohort 5
The highest dose level of HM10760A
 Drug: HM10760A or placebo
Once, 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
  • To evaluate the pharmacokinetic profiles of single IV dose levels of HM10760A in healthy adult Caucasian and Japanese subjects.
  • To determine the pharmacologically active dose (PAD) of HM10760A (EPO) administered intravenously in healthy adult Caucasian and Japanese subjects
  • To assess the immunogenicity of a single IV dose of HM10760A.
  Eligibility

Ages Eligible for Study:   18 Years to 55 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Healthy Caucasian and Japanese male and/or female volunteers
  • 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:

  • 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
Please refer to this study by its ClinicalTrials.gov identifier: NCT01030315

Locations
United States, California
California Clinical Trials
Glendale, California, United States, 91206
Sponsors and Collaborators
Hanmi Pharmaceutical Company Limited
Investigators
Principal Investigator: Mark Yen, MD California Clinical Trials Medical Group
  More Information

No publications provided

Responsible Party: Kyungmi Park / Director, Hanmi Pharmaceutical Company., Limited.
ClinicalTrials.gov Identifier: NCT01030315     History of Changes
Other Study ID Numbers: 09-HM10760A-101
Study First Received: December 10, 2009
Last Updated: April 26, 2011
Health Authority: United States: Food and Drug Administration

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

Additional relevant MeSH terms:
Epoetin Alfa
Hematinics
Hematologic Agents
Therapeutic Uses
Pharmacologic Actions

ClinicalTrials.gov processed this record on May 23, 2013