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

2014-08-27 03:18:02 | BioPortfolio

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

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

Study Design

Allocation: Randomized, Control: Placebo Control, Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Treatment

Conditions

Healthy

Intervention

HM10760A or Placebo

Location

Seoul National University Hospital
Seoul
Korea, Republic of
110-744

Status

Recruiting

Source

Hanmi Pharmaceutical Company Limited

Results (where available)

View Results

Links

Published on BioPortfolio: 2014-08-27T03:18:02-0400

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