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A Study of HM10760A (Long-acting Erythropoietin) in Healthy Adult Caucasian and Japanese Subjects

2014-08-27 03:17:20 | BioPortfolio

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.

Description

Secondary Objectives:

- To evaluate the dose response relationship of a single IV dose of HM10760A on pharmacodynamic parameters

- To evaluate the pharmacokinetic profiles of single IV dose levels of HM10760A in healthy adult Caucasian and Japanese subjects.

- To determine the pharmacologically active dose (PAD) of HM10760A (EPO) administered intravenously in healthy adult Caucasian and Japanese subjects

- 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

California Clinical Trials
Glendale
California
United States
91206

Status

Recruiting

Source

Hanmi Pharmaceutical Company Limited

Results (where available)

View Results

Links

Published on BioPortfolio: 2014-08-27T03:17:20-0400

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