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

Completed

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Key information

Conditions

Healthy

Age range

20 year–55 year

Sex eligibility

Male

Study type

Interventional

Phase

Phase 1

Primary location

Hanmi Clinical

Seoul, South Korea

About this study

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

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

HM10760A or Placebo

Drug

0.04 mcg/kg to 2.0mcg/kg once intravenously

Primary outcomes

Safety data, including physical examinations, laboratory evaluation, ECGs, vital signs, adverse events, and immunogenicity

Time frame: 84 days

Sponsors and collaborators

Lead sponsor

Hanmi Pharmaceutical Company Limited

Industry

Registry information

Official study title

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

Important dates

Study start: 2009
Primary completion: 2010
Study completion: 2011
First posted: Nov 13, 2009
Registry last updated: Feb 7, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed