NCT01013064

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
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 48 (actual)
• Sponsor: Hanmi Pharmaceutical Company Limited · Industry
• Sex: Male
• Age: 20 Years – 55 Years
• Healthy volunteers: Accepted

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

Conditions

• Healthy

Interventions

Type	Name	Description
DRUG	HM10760A or Placebo	0.04 mcg/kg to 2.0mcg/kg once intravenously

Timeline

• Start date: 2009-11-01
• Primary completion: 2010-12-01
• Completion: 2011-01-01
• First posted: 2009-11-13
• Last updated: 2014-02-07

Locations

1 site across 1 country: South Korea