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

Hanmi Pharmaceutical

Status and phase: Completed; Phase 1

Conditions: Healthy

Treatments: Drug: HM10760A or Placebo

Study type: Interventional

Funder types: Industry

Identifiers

NCT01013064

09-HM10760A-102

Details and patient eligibility

About

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

Full 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

Enrollment: 48 patients

Sex: Male

Ages: 20 to 55 years old

Volunteers: Accepts Healthy Volunteers

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)

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Single Group Assignment

Masking: Triple Blind

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48 participants in 6 patient groups

Cohort1

Experimental group

Treatment:

Drug: HM10760A or Placebo

Cohort2

Experimental group

Treatment:

Drug: HM10760A or Placebo

Cohort3

Experimental group

Treatment:

Drug: HM10760A or Placebo

Cohort4

Experimental group

Treatment:

Drug: HM10760A or Placebo

Cohort5

Experimental group

Treatment:

Drug: HM10760A or Placebo

Cohort6

Experimental group

Treatment:

Drug: HM10760A or Placebo