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

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Hanmi Pharmaceutical

Status and phase

Completed
Phase 1

Conditions

Healthy

Treatments

Drug: HM10760A or placebo

Study type

Interventional

Funder types

Industry

Identifiers

NCT01030315
09-HM10760A-101

Details and patient eligibility

About

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.

Full 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.

Enrollment

65 patients

Sex

All

Ages

18 to 55 years old

Volunteers

Accepts Healthy Volunteers

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)

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Single Group Assignment

Masking

Triple Blind

65 participants in 5 patient groups

Cohort 1
Experimental group
Description:
The lowest dose level of HM10760A
Treatment:
Drug: HM10760A or placebo
Cohort 2
Experimental group
Description:
Second dose level of HM10760A
Treatment:
Drug: HM10760A or placebo
Cohort 3
Experimental group
Description:
Third dose level of HM10760A
Treatment:
Drug: HM10760A or placebo
Cohort 4
Experimental group
Description:
Fourth dose level of HM10760A
Treatment:
Drug: HM10760A or placebo
Cohort 5
Experimental group
Description:
The highest dose level of HM10760A
Treatment:
Drug: HM10760A or placebo

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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