NCT01013064

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
48

participants targeted

Target at P50-P75 for phase_1 healthy

Timeline
Completed

Started Nov 2009

Longer than P75 for phase_1 healthy

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 1, 2009

Completed
9 days until next milestone

First Submitted

Initial submission to the registry

November 10, 2009

Completed
3 days until next milestone

First Posted

Study publicly available on registry

November 13, 2009

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2010

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2011

Completed
Last Updated

February 7, 2014

Status Verified

February 1, 2014

Enrollment Period

1.1 years

First QC Date

November 10, 2009

Last Update Submit

February 6, 2014

Conditions

Healthy

Keywords

ErythropoietinLong actingEPO

Outcome Measures

Primary Outcomes (1)

  • Safety data, including physical examinations, laboratory evaluation, ECGs, vital signs, adverse events, and immunogenicity

    84 days

Study Arms (6)

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

HM10760A or PlaceboDRUG

0.04 mcg/kg to 2.0mcg/kg once intravenously

Cohort1Cohort2Cohort3Cohort4Cohort5Cohort6

Eligibility Criteria

Age20 Years - 55 Years
Sexmale
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

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

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)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hanmi Clinical

Seoul, South Korea

Location

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 10, 2009

First Posted

November 13, 2009

Study Start

November 1, 2009

Primary Completion

December 1, 2010

Study Completion

January 1, 2011

Last Updated

February 7, 2014

Record last verified: 2014-02

Locations

KR(1)