NCT02725086

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

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

Enrollment
56

participants targeted

Target at P75+ for phase_1 healthy

Timeline
Completed

Started Feb 2016

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

February 1, 2016

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

March 22, 2016

Completed
9 days until next milestone

First Posted

Study publicly available on registry

March 31, 2016

Completed
1 day until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2016

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2016

Completed
Last Updated

November 10, 2016

Status Verified

November 1, 2016

Enrollment Period

2 months

First QC Date

March 22, 2016

Last Update Submit

November 9, 2016

Conditions

Healthy

Outcome Measures

Primary Outcomes (4)

  • AUCinf of Filgrastim

    PK parameter

    0~48 hr

  • Cmax of Filgrastim

    PK parameter

    0~48 hr

  • AUEC0-t of ANC(absolute neutrophil count)

    PD parameter

    0~120 hr

  • Emax of ANC(absolute neutrophil count)

    PD parameter

    0~120 hr

Secondary Outcomes (6)

  • Tmax of Filgrastim

    0~48 hr

  • AUC0-t of Filgrastim

    0~48 hr

  • CL/F of Filgrastim

    0~48 hr

  • Vd/F of Filgrastim

    0~48 hr

  • AUEC0-t of CD34+ cell count

    0~312 hr

  • +1 more secondary outcomes

Study Arms (2)

Part 1; Filgrastim 5 ㎍/kg

EXPERIMENTAL

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®Drug: Neupogen®

Part 2; Filgrastim 10 ㎍/kg

EXPERIMENTAL

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®Drug: Neupogen®

Interventions

Leucostim®DRUG
Also known as: DA-3030
Part 1; Filgrastim 5 ㎍/kgPart 2; Filgrastim 10 ㎍/kg
Neupogen®DRUG
Part 1; Filgrastim 5 ㎍/kgPart 2; Filgrastim 10 ㎍/kg

Eligibility Criteria

Age19 Years - 45 Years
Sexmale
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Severance Hospital, Yonsei University College of Medicine

Seoul, Seodamun-gu, 03722, South Korea

Location

MeSH Terms

Interventions

Filgrastim

Intervention Hierarchy (Ancestors)

Granulocyte Colony-Stimulating FactorColony-Stimulating FactorsGlycoproteinsGlycoconjugatesCarbohydratesHematopoietic Cell Growth FactorsCytokinesIntercellular Signaling Peptides and ProteinsPeptidesAmino Acids, Peptides, and ProteinsProteinsBiological Factors

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
CROSSOVER
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 22, 2016

First Posted

March 31, 2016

Study Start

February 1, 2016

Primary Completion

April 1, 2016

Study Completion

May 1, 2016

Last Updated

November 10, 2016

Record last verified: 2016-11

Locations

KR(1)