A Study of HM10760A (Long-acting Erythropoietin (EPO)) in... | NCT01013064

Studies
A Study of HM10760A (Long-acting Erythropoietin (EPO)) in Healthy Korean Subjects

NCT01013064

Sponsor

Hanmi Pharmaceutical Company Limited

Status

Completed

Last Update Posted

Feb 7, 2014Estimated

Enrollment

48Actual

Phase

Phase 1

Conditions

Healthy

Interventions

HM10760A or Placebo

Countries

South Korea

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Feb 2014

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Nov 2009

Primary Completion Date

Dec 2010Actual

Completion Date

Jan 2011Actual

First Submitted Date

Nov 10, 2009

First Submission Date that Met QC Criteria

Nov 12, 2009

First Posted Date

Nov 13, 2009Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Feb 6, 2014

Last Update Posted Date

Feb 7, 2014Estimated

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

Study design:

Randomized, double-blind, placebo-controlled, sequential dose escalation
Six ascending dose cohorts are planned

Primary Objective:

To evaluate the safety profile of single escalating intravenous dose levels of HM10760A

Detailed Description

Secondary objectives:

To evaluate the dose response relationship of a single IV dose of HM10760A on pharmacodynamic parameters including hemoglobin, reticulocyte count, and reticulocyte hemoglobin content
To evaluate the pharmacokinetic profiles of single IV dose levels of HM10760A
To determine the pharmacologically active dose(PAD) of HM10760A
To assess the immunogenicity of a single IV dose of HM10760A

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 1

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

48Actual

Arms/Interventions Module

Arm Groups

Label	Type	Intervention Names
Cohort1	Experimental	Drug: HM10760A or Placebo
Cohort2	Experimental	Drug: HM10760A or Placebo
Cohort3	Experimental	Drug: HM10760A or Placebo
Cohort4	Experimental	Drug: HM10760A or Placebo
Cohort5	Experimental	Drug: HM10760A or Placebo
Cohort6	Experimental	Drug: HM10760A or Placebo

Interventions

Name	Type	Description	Arm Group Labels	Other Names
HM10760A or Placebo	Drug	0.04 mcg/kg to 2.0mcg/kg once intravenously	Cohort1 Cohort2 Cohort3 Cohort4 Cohort5

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Safety data, including physical examinations, laboratory evaluation, ECGs, vital signs, adverse events, and immunogenicity		84 days

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Age 20 to 55 years
Able and willing to provided written informed consent
Hemoglobin < 16 g/dL

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)

Accepts Healthy Volunteers

Yes

Sex

Male

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

20 Years

Maximum Age

55 Years

Standard Ages

Adult

Study Population

Not provided

Sampling Method

Not provided