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

Phase 1

Completed

• Conditions: Healthy
• Interventions: Drug: Leucostim®; Drug: Neupogen®

• Registration Number: NCT02725086
• Lead Sponsor: Dong-A ST Co., Ltd.

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

Detailed Description

Not available

Study Timeline

• Study Start: 2016-02
• Study First Submitted: 2016-03-22
• Study First Submitted QC: 2016-03-27
• Study First Posted: 2016-03-31
• Primary Completion: 2016-04
• Study Completion: 2016-05
• Status Verified: 2016-11
• Last Update Submitted: 2016-11-09
• Last Update Posted: 2016-11-10

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Male
• Target Recruitment: 56

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Part 2; Filgrastim 10 ㎍/kg	Leucostim®	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.
Part 2; Filgrastim 10 ㎍/kg	Neupogen®	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.
Part 1; Filgrastim 5 ㎍/kg	Leucostim®	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.
Part 1; Filgrastim 5 ㎍/kg	Neupogen®	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.

Primary Outcome Measures

Name	Time	Method
Cmax of Filgrastim	0~48 hr	PK parameter
AUCinf of Filgrastim	0~48 hr	PK parameter
AUEC0-t of ANC(absolute neutrophil count)	0~120 hr	PD parameter
Emax of ANC(absolute neutrophil count)	0~120 hr	PD parameter

Secondary Outcome Measures

Name	Time	Method
Tmax of Filgrastim	0~48 hr	PK parameter
AUC0-t of Filgrastim	0~48 hr	PK parameter
CL/F of Filgrastim	0~48 hr	PK parameter
AUEC0-t of CD34+ cell count	0~312 hr	PD parameter
Emax of CD34+ cell count	0~312 hr	PD parameter
Vd/F of Filgrastim	0~48 hr	PD parameter

Trial Locations

Locations (1)

Severance Hospital, Yonsei University College of Medicine; 🇰🇷 Seoul, Seodamun-gu, Korea, Republic of