drugset / Trial / NCT01030315

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

NCT01030315 ↗

Phase 1 Completed 65 enrolled Hanmi Pharmaceutical Company Limited
RandomizedSingle-groupTriple-blindTreatment

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.

Timeline

Start
2009-10
Primary completion
2010-12
Completion
2011-01

Drugs

EvaluationDrugModalityDoseRoute
Subject HM10760A Protein / enzyme biologic 0.04 ug/kg Intravenous
Subject HM10760A Protein / enzyme biologic 2 ug/kg Intravenous

Indications

No indication recorded.