Evaluation of Pharmacokinetic/Pharmacodynamic Properties and Safety of Leucostim® Compared to Neupogen® in Healthy Adult Volunteers

November 9, 2016 updated by: Dong-A ST Co., Ltd.
A Randomized, Open-label, Two-way Crossover, Open-label Clinical Trial to Compare Pharmacokinetic/Pharmacodynamic Properties and Safety after Subcutaneous Administration of Leucostim® and Neupogen® in Healthy Adult Volunteers

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

56

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Korea, Republic of
    • Seodamun-gu
      • Seoul, Seodamun-gu, Korea, Republic of, 03722
        • Severance Hospital, Yonsei University College of Medicine

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

19 years to 45 years (Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

Male

Description

Inclusion Criteria:

  • Age 19 - 45 years
  • BMI 18.5 - 25.0 kg/m2
  • Value of ANC(absolute neutrophil count) had to be inside the normality range at the screening

Exclusion Criteria:

  • Subjects with a history or presence of clinically relevant hypersensitivity reaction to investigational drugs (G-CSF) or their ingredients/additives
  • Subjects with a clinically relevant history of allergic reaction
  • Subjects with a history of acute infectious diseases within 2 weeks prior to administration of investigational products
  • At the investigator's discretion, subjects who is considered inappropriate to participate in the study due to any conditions including screening results

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Part 1; Filgrastim 5 ㎍/kg
Neupogen®(Filgrastim) 5 ㎍/kg or Leucostim®(Filgrastim) 5 ㎍/kg will be administered subcutaneously on Period 1, Day 1. And wash out for 28 days or more. Leucostim®(Filgrastim) 5 ㎍/kg or Neupogen®(Filgrastim) 5 ㎍/kg will be administered subcutaneously on Period 2, Day 1.
Drug: Leucostim®
Other Names:
  • DA-3030
Drug: Neupogen®
Experimental: Part 2; Filgrastim 10 ㎍/kg
Neupogen®(Filgrastim) 10 ㎍/kg or Leucostim®(Filgrastim) 10 ㎍/kg will be administered subcutaneously on Period 1, Day 1. And wash out for 28 days or more. Leucostim®(Filgrastim) 10 ㎍/kg or Neupogen®(Filgrastim) 10 ㎍/kg will be administered subcutaneously on Period 2, Day 1.
Drug: Leucostim®
Other Names:
  • DA-3030
Drug: Neupogen®

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
AUCinf of Filgrastim
Time Frame: 0~48 hr
PK parameter
0~48 hr
Cmax of Filgrastim
Time Frame: 0~48 hr
PK parameter
0~48 hr
AUEC0-t of ANC(absolute neutrophil count)
Time Frame: 0~120 hr
PD parameter
0~120 hr
Emax of ANC(absolute neutrophil count)
Time Frame: 0~120 hr
PD parameter
0~120 hr

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Tmax of Filgrastim
Time Frame: 0~48 hr
PK parameter
0~48 hr
AUC0-t of Filgrastim
Time Frame: 0~48 hr
PK parameter
0~48 hr
CL/F of Filgrastim
Time Frame: 0~48 hr
PK parameter
0~48 hr
Vd/F of Filgrastim
Time Frame: 0~48 hr
PD parameter
0~48 hr
AUEC0-t of CD34+ cell count
Time Frame: 0~312 hr
PD parameter
0~312 hr
Emax of CD34+ cell count
Time Frame: 0~312 hr
PD parameter
0~312 hr

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Dong-A ST Co., Ltd.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

February 1, 2016

Primary Completion (Actual)

April 1, 2016

Study Completion (Actual)

May 1, 2016

Study Registration Dates

First Submitted

March 22, 2016

First Submitted That Met QC Criteria

March 27, 2016

First Posted (Estimate)

March 31, 2016

Study Record Updates

Last Update Posted (Estimate)

November 10, 2016

Last Update Submitted That Met QC Criteria

November 9, 2016

Last Verified

November 1, 2016

More Information

Terms related to this study

Other Study ID Numbers

  • DA3030_NP_I

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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