A Study of HM10760A (Long-acting Erythropoietin) in Healthy Adult Caucasian and Japanese Subjects
| Status: | Archived |
|---|---|
| Conditions: | Healthy Studies |
| Therapuetic Areas: | Other |
| Healthy: | No |
| Age Range: | Any |
| Updated: | 7/1/2011 |
| Start Date: | October 2009 |
| End Date: | November 2010 |
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
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.
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.
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