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

Dong-A ST

Status and phase: Completed; Phase 1

Conditions: Healthy

Treatments: Drug: Leucostim®; Drug: Neupogen®

Study type: Interventional

Funder types: Industry

Identifiers

NCT02725086

DA3030_NP_I

Details and patient eligibility

About

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

Enrollment: 56 estimated patients

Sex: Male

Ages: 19 to 45 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: None (Open label)

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56 participants in 2 patient groups

Part 1; Filgrastim 5 ㎍/kg

Experimental group

Description:

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.

Treatment:

Drug: Leucostim®

Drug: Neupogen®

Part 2; Filgrastim 10 ㎍/kg

Experimental group

Description:

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.

Treatment:

Drug: Leucostim®

Drug: Neupogen®