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

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ClinicalTrials.gov Identifier: NCT01030315
Recruitment Status : Completed
First Posted : December 11, 2009
Last Update Posted : February 26, 2014
Sponsor:
Information provided by (Responsible Party):
Hanmi Pharmaceutical Company Limited

Brief Summary:

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 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
  • To assess the immunogenicity of a single IV dose of HM10760A.

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 65 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 Caucasian and Japanese Subjects
Study Start Date : October 2009
Actual Primary Completion Date : December 2010
Actual Study Completion Date : January 2011

Arm Intervention/treatment
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




Primary Outcome Measures :
  1. 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. ]


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Ages Eligible for Study:   18 Years to 55 Years   (Adult)
Sexes Eligible for Study:   All
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)

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): NCT01030315


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

Responsible Party: Hanmi Pharmaceutical Company Limited
ClinicalTrials.gov Identifier: NCT01030315     History of Changes
Other Study ID Numbers: 09-HM10760A-101
First Posted: December 11, 2009    Key Record Dates
Last Update Posted: February 26, 2014
Last Verified: February 2014

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

Additional relevant MeSH terms:
Epoetin Alfa
Hematinics