NCT01030315

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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
65

participants targeted

Target at P75+ for phase_1 healthy

Timeline
Completed

Started Oct 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

October 1, 2009

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

December 10, 2009

Completed
1 day until next milestone

First Posted

Study publicly available on registry

December 11, 2009

Completed
12 months 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 26, 2014

Status Verified

February 1, 2014

Enrollment Period

1.2 years

First QC Date

December 10, 2009

Last Update Submit

February 24, 2014

Conditions

Healthy

Keywords

ErythropoietinLong-actingEPO

Outcome Measures

Primary Outcomes (1)

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

    84 days after the investigational drug administration.

Study Arms (5)

Cohort 1

EXPERIMENTAL

The lowest dose level of HM10760A

Drug: HM10760A or placebo

Cohort 2

EXPERIMENTAL

Second dose level of HM10760A

Drug: HM10760A or placebo

Cohort 3

EXPERIMENTAL

Third dose level of HM10760A

Drug: HM10760A or placebo

Cohort 4

EXPERIMENTAL

Fourth dose level of HM10760A

Drug: HM10760A or placebo

Cohort 5

EXPERIMENTAL

The highest dose level of HM10760A

Drug: HM10760A or placebo

Interventions

HM10760A or placeboDRUG

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

Cohort 1Cohort 2Cohort 3Cohort 4Cohort 5

Eligibility Criteria

Age18 Years - 55 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • 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

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

US, California, United States

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

December 10, 2009

First Posted

December 11, 2009

Study Start

October 1, 2009

Primary Completion

December 1, 2010

Study Completion

January 1, 2011

Last Updated

February 26, 2014

Record last verified: 2014-02

Locations

US(1)