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

NCT ID: NCT02725086

Last Updated: 2016-11-10

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

56 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-02-29

Study Completion Date

2016-05-31

Brief Summary

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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

Detailed Description

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Conditions

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Healthy

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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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.

Group Type EXPERIMENTAL

Leucostim®

Intervention Type DRUG

Neupogen®

Intervention Type DRUG

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.

Group Type EXPERIMENTAL

Leucostim®

Intervention Type DRUG

Neupogen®

Intervention Type DRUG

Interventions

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Leucostim®

Intervention Type DRUG

Neupogen®

Intervention Type DRUG

Other Intervention Names

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DA-3030

Eligibility Criteria

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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
Minimum Eligible Age

19 Years

Maximum Eligible Age

45 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

Yes

Sponsors

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Dong-A ST Co., Ltd.

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Severance Hospital, Yonsei University College of Medicine

Seoul, Seodamun-gu, South Korea

Site Status

Countries

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South Korea

Other Identifiers

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DA3030_NP_I

Identifier Type: -

Identifier Source: org_study_id