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

Phase 1

Completed

• Conditions: Healthy
• Interventions: Drug: HM10760A or placebo

• Registration Number: NCT01030315
• Lead Sponsor: Hanmi Pharmaceutical Company Limited

Brief 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.

Detailed 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.

Study Timeline

• Study Start: 2009-10
• Study First Submitted: 2009-12-10
• Study First Submitted QC: 2009-12-10
• Study First Posted: 2009-12-11
• Primary Completion: 2010-12
• Study Completion: 2011-01
• Status Verified: 2014-02
• Last Update Submitted: 2014-02-24
• Last Update Posted: 2014-02-26

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 65

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)

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Cohort 1	HM10760A or placebo	The lowest dose level of HM10760A
Cohort 2	HM10760A or placebo	Second dose level of HM10760A
Cohort 3	HM10760A or placebo	Third dose level of HM10760A
Cohort 4	HM10760A or placebo	Fourth dose level of HM10760A
Cohort 5	HM10760A or placebo	The highest dose level of HM10760A

Primary Outcome Measures

Name	Time	Method
Safety data, including physical examinations, laboratory evaluation, ECGs, vital signs, adverse events, and endogenous erythropoietin level.	84 days after the investigational drug administration.

Trial Locations

Locations (1)

Hanmi Clinical; 🇺🇸 US, California, United States