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

NCT01013064 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 48

Last updated 2014-02-07

No results posted yet for this study

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

Conditions

  • Healthy

Interventions

DRUG

HM10760A or Placebo

0.04 mcg/kg to 2.0mcg/kg once intravenously

Sponsors & Collaborators

  • Hanmi Pharmaceutical Company Limited

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
SINGLE_GROUP

Eligibility

Min Age
20 Years
Max Age
55 Years
Sex
MALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2009-11-30
Primary Completion
2010-12-31
Completion
2011-01-31

Countries

  • South Korea

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01013064 on ClinicalTrials.gov