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OpenTrials
Completed

NCT Number: NCT02725086

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

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

Completed

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Key information

Conditions

Healthy

Age range

19 year–45 year

Sex eligibility

Male

Study type

Interventional

Phase

Phase 1

Primary location

Severance Hospital, Yonsei University College of Medicine

Seoul, Seodamun-gu, 03722, South Korea

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Leucostim®

Drug

Other names: DA-3030

Neupogen®

Drug

Primary outcomes

  1. AUCinf of Filgrastim

    Time frame: 0~48 hr

    PK parameter

  2. Cmax of Filgrastim

    Time frame: 0~48 hr

    PK parameter

  3. AUEC0-t of ANC(absolute neutrophil count)

    Time frame: 0~120 hr

    PD parameter

  4. Emax of ANC(absolute neutrophil count)

    Time frame: 0~120 hr

    PD parameter

Secondary outcomes

  1. Tmax of Filgrastim

    Time frame: 0~48 hr

    PK parameter

  2. AUC0-t of Filgrastim

    Time frame: 0~48 hr

    PK parameter

  3. CL/F of Filgrastim

    Time frame: 0~48 hr

    PK parameter

  4. Vd/F of Filgrastim

    Time frame: 0~48 hr

    PD parameter

  5. AUEC0-t of CD34+ cell count

    Time frame: 0~312 hr

    PD parameter

  6. Emax of CD34+ cell count

    Time frame: 0~312 hr

    PD parameter

Sponsors and collaborators

Lead sponsor

Dong-A ST Co., Ltd.

Industry

Registry information

Important dates

Study start
2016
Primary completion
2016
Study completion
2016
First posted
Mar 31, 2016
Registry last updated
Nov 10, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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