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

Status

Completed

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01013064

Enrollment

Registered

2009-11-13

Start date

2009-11-30

Completion date

2011-01-31

Last updated

2014-02-07

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Healthy

Keywords

Erythropoietin, Long acting, EPO

Brief summary

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

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

Interventions

DRUGHM10760A or Placebo

0.04 mcg/kg to 2.0mcg/kg once intravenously

Study design

Allocation

RANDOMIZED

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

TRIPLE (Subject, Caregiver, Investigator)

Eligibility

Sex/Gender

MALE

Age

20 Years to 55 Years

Healthy volunteers

Yes

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)

Design outcomes

Primary

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

Countries

South Korea

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026