drugset / Trial / NCT01030315
A Study of HM10760A (Long-acting Erythropoietin) in Healthy Adult Caucasian and Japanese Subjects
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
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | HM10760A | Protein / enzyme biologic | 0.04 ug/kg | Intravenous |
| Subject | HM10760A | Protein / enzyme biologic | 2 ug/kg | Intravenous |
Indications
No indication recorded.