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

Completed · Phase 1 · Has a placebo group

Conditions studied: Healthy

In brief

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.

Key facts

Study ID

NCT01030315

Run by

Hanmi Pharmaceutical Company Limited

People needed

65

Starts

2009-10-01

Expected to finish

2011-01-01

Last updated by the study team

2014-02-26

Who can join

Age: 18 and older, up to 55. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• Healthy Caucasian and Japanese male and/or female volunteers
• Age 18 to 55 years
• Hemoglobin of >12 g/dL and <16 g/dL for male subjects, >10 g/dL and <14 g/dL for female Caucasian subjects

You may not qualify if…

• Prior exposure to EPO, darbepoetin, other EPO support proteins
• hypersensitivity to EPO, darbepoetin, E.coli derived proteins
• Hemoglobinopathy
• SBP > 140 mmHg or < 90 mmHg or DBP > 95 mmHg
• Chronic, uncontrolled, or symptomatic inflammatory disease
• Malignancy(except non-melanoma skin cancer)

Where it is running

• Hanmi Clinical — US, California, United States

Full record on ClinicalTrials.gov

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