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

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

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

Study Overview

• Status: Completed
• Conditions: Healthy
• Intervention / Treatment: Drug: HM10760A or Placebo

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

• Study Type: Interventional
• Enrollment (Actual): 48
• Phase: Phase 1

Contacts and Locations

Study Locations

• Korea, Republic of
  • Seoul, Korea, Republic of
    • Hanmi Clinical

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 20 years to 55 years (Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: Male

Description

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)

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Single Group Assignment
• Masking: Triple

Number of Arms

6

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Safety data, including physical examinations, laboratory evaluation, ECGs, vital signs, adverse events, and immunogenicity	84 days

Collaborators and Investigators

• Sponsor: Hanmi Pharmaceutical Company Limited

Study record dates

Study Major Dates

• Study Start: November 1, 2009
• Primary Completion (Actual): December 1, 2010
• Study Completion (Actual): January 1, 2011

Study Registration Dates

• First Submitted: November 10, 2009
• First Submitted That Met QC Criteria: November 12, 2009
• First Posted (Estimate): November 13, 2009

Study Record Updates

• Last Update Posted (Estimate): February 7, 2014
• Last Update Submitted That Met QC Criteria: February 6, 2014
• Last Verified: February 1, 2014

More Information

Terms related to this study

• Keywords: Erythropoietin; Long acting; EPO
• Other Study ID Numbers: 09-HM10760A-102