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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Hanmi Pharmaceutical Company Limited
ClinicalTrials.gov Identifier:
NCT01030315
First received: December 10, 2009
Last updated: February 24, 2014
Last verified: February 2014
  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

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 ]

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 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
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: NCT01030315

Locations
United States, California
Hanmi Clinical
US, California, United States
Sponsors and Collaborators
Hanmi Pharmaceutical Company Limited
  More Information

No publications provided

Responsible Party: 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: February 24, 2014
Health Authority: United States: Food and Drug Administration

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

ClinicalTrials.gov processed this record on September 30, 2014