NCT01030315

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
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 65 (actual)
• Sponsor: Hanmi Pharmaceutical Company Limited · Industry
• Sex: All
• Age: 18 Years – 55 Years
• Healthy volunteers: Accepted

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.

Conditions

• Healthy

Interventions

Type	Name	Description
DRUG	HM10760A or placebo	Once, 0.04 mcg/kg to 2.0mcg/kg once intravenously

Timeline

• Start date: 2009-10-01
• Primary completion: 2010-12-01
• Completion: 2011-01-01
• First posted: 2009-12-11
• Last updated: 2014-02-26

Locations

1 site across 1 country: United States