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

Status

Completed

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01030315

Acronym

EPO

Enrollment

Registered

2009-12-11

Start date

2009-10-31

Completion date

2011-01-31

Last updated

2014-02-26

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: * 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.

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.

Interventions

DRUGHM10760A or placebo

Once, 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

ALL

Age

18 Years to 55 Years

Healthy volunteers

Yes

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)

Design outcomes

Primary

Measure	Time frame
Safety data, including physical examinations, laboratory evaluation, ECGs, vital signs, adverse events, and endogenous erythropoietin level.	84 days after the investigational drug administration.

Countries

United States

Outcome results

None listed

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