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- 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.
- To evaluate safety profile of single intravenous (IV) dose levels of HM10760A in healthy adult Caucasian and Japanese subjects.
- 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.
Allocation: Randomized, Control: Placebo Control, Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Treatment
HM10760A or placebo
California Clinical Trials
Hanmi Pharmaceutical Company Limited
Published on BioPortfolio: 2014-08-27T03:17:20-0400
Study design: - Randomized, double-blind, placebo-controlled, sequential dose escalation - Six ascending dose cohorts are planned Primary Objective: - To evaluate ...
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