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

Hanmi Pharmaceutical

Status and phase: Completed; Phase 1

Conditions: Healthy

Treatments: Drug: HM10760A or placebo

Study type: Interventional

Funder types: Industry

Identifiers

NCT01030315

09-HM10760A-101

Details and patient eligibility

About

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.

Full description

Secondary Objectives:

To evaluate the dose response relationship of a single IV dose of HM10760A on pharmacodynamic parameters To assess the immunogenicity of a single IV dose of HM10760A.

Enrollment: 65 patients

Sex: All

Ages: 18 to 55 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• 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

Exclusion criteria

• 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)

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Single Group Assignment

Masking: Triple Blind

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65 participants in 5 patient groups

Cohort 1

Experimental group

Description:

The lowest dose level of HM10760A

Treatment:

Drug: HM10760A or placebo

Cohort 2

Experimental group

Description:

Second dose level of HM10760A

Treatment:

Drug: HM10760A or placebo

Cohort 3

Experimental group

Description:

Third dose level of HM10760A

Treatment:

Drug: HM10760A or placebo

Cohort 4

Experimental group

Description:

Fourth dose level of HM10760A

Treatment:

Drug: HM10760A or placebo

Cohort 5

Experimental group

Description:

The highest dose level of HM10760A

Treatment:

Drug: HM10760A or placebo