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

Hanmi Pharmaceutical Company Limited65 enrolled

Overview

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.

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

TRIPLE

Enrollment

Conditions

Healthy

Interventions

HM10760A or placeboDRUG

Once, 0.04 mcg/kg to 2.0mcg/kg once intravenously

Eligibility

Sex: ALLMin age: 18 YearsMax age: 55 YearsHealthy volunteers:

Medical Language ↔ Plain English

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)

Locations (1)

Hanmi Clinical

US, California, United States

Outcomes

Primary Outcomes

Safety data, including physical examinations, laboratory evaluation, ECGs, vital signs, adverse events, and endogenous erythropoietin level.

Time frame: 84 days after the investigational drug administration.

Data from ClinicalTrials.gov

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