NCT01037543

Brief Summary

Study Design

  • Randomized, double-blind, placebo-controlled, escalating single-dose design.
  • Six ascending dose cohorts
  • In each cohorts, subjects will be randomized to receive a single dose of HM10460A, placebo (negative control), or Neulasta® (positive control).
  • Primary Objective
  • to assess the safety and tolerability of single escalating subcutaneous doses of HM10460A in healthy adult Japanese and Caucasian subjects.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
84

participants targeted

Target at 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
2 months until next milestone

First Submitted

Initial submission to the registry

December 21, 2009

Completed
2 days until next milestone

First Posted

Study publicly available on registry

December 23, 2009

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2011

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2011

Completed
Last Updated

February 7, 2014

Status Verified

February 1, 2014

Enrollment Period

1.3 years

First QC Date

December 21, 2009

Last Update Submit

February 5, 2014

Conditions

Healthy

Outcome Measures

Primary Outcomes (2)

  • Safety data, including physical examinations (to include injection site reactions and splenic evaluations), laboratory evaluations, ECGs, vital signs assessments, and adverse effects (AEs).

    Time points where appropriate.

  • Samples for immunogenicity

    Days -1, 15, 22, and 42.

Secondary Outcomes (2)

  • PK parameters measured from Serum and Urine samples.

    Serum samples: pre-dose, 0.25, 0.5, 0.75, 1, 2, 3, 4, 6, 8, 12, 16, 24, 36, 48 hrs, Days 4, 5, 6, 7, 11, 15, and 22. / Urine Samples: 0 - 6, 6 - 12, 12 - 24, 24 - 36, and 36 - 48 hours post-dose.

  • Calculation of ANC and CD34+ cell counts.

    pre-dose, 24 and 48 hours post-dose, Days 4, 5, 6, 7, 11, 15, and 22.

Study Arms (6)

Cohort 1

EXPERIMENTAL

1.1 mcg/kg of HM10460A, placebo, or Neulasta

Drug: HM10460A or placebo or Neulasta

Cohort 2

EXPERIMENTAL

3.3 mcg/kg HM10460A, placebo or Neulasta

Drug: HM10460A or placebo or Neulasta

Cohort 3

EXPERIMENTAL

10 mcg/kg of HM10460A, placebo, or Neulasta

Drug: HM10460A or placebo or Neulasta

Cohort 4

EXPERIMENTAL

30 mcg/kg of HM10460A, placebo, or Neulasta

Drug: HM10460A or placebo or Neulasta

Cohort 5

EXPERIMENTAL

90 mcg/kg or HM10460A, placebo, or Neulasta

Drug: HM10460A or placebo or Neulasta

Cohort 6

EXPERIMENTAL

270 mcg/kg of HM10460A, placebo, or Neulasta

Drug: HM10460A or placebo or Neulasta

Interventions

HM10460A or placebo or NeulastaDRUG

Single SC injection of the appropriate dose of drug ranging from 1.1 mcg/kg to 270 mcg/kg.

Also known as: LAPS-G-CSF
Cohort 1Cohort 2Cohort 3Cohort 4Cohort 5Cohort 6

Eligibility Criteria

Age20 Years - 45 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • BMI of 18 - 29.9 kg/m2
  • have not used tobacco or nicotine containing products for at least 3 months prior to dosing
  • be able to remain abstinent throughout the study.

You may not qualify if:

  • History or presence of significant cardiovascular, pulmonary, hepatic, renal, hematological, gastrointestinal, endocrine, immunologic, dermatologic, neurological, or psychiatric disease.
  • positive urine drug/alcohol testing
  • Positive for HIV, HBsAg, HCV ab
  • History of anaphylactic reaction to medicine or environmental exposure

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Unknown Facility

California City, California, United States

Location

Related Publications (1)

  • Jeon Y, Lee N, Baek S, Choi J, Jhee S, Lee H. A Randomized, Double-Blind, Placebo- and Active-Controlled, Escalating Single-Dose Study to Evaluate the Safety, Tolerability, Pharmacokinetic, and Pharmacodynamic Profiles of Subcutaneous Eflapegrastim in Healthy Japanese and Caucasian Subjects. Drugs R D. 2022 Mar;22(1):71-87. doi: 10.1007/s40268-021-00379-8. Epub 2022 Jan 6.

    PMID: 34993933DERIVED

MeSH Terms

Interventions

eflapegrastimpegfilgrastim

Study Officials

  • Hanmi Clinical

    California

    PRINCIPAL INVESTIGATOR

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 21, 2009

First Posted

December 23, 2009

Study Start

November 1, 2009

Primary Completion

February 1, 2011

Study Completion

April 1, 2011

Last Updated

February 7, 2014

Record last verified: 2014-02

Locations

US(1)