Pharmacokinetic/Pharmacodynamic (PK/PD) Study Evaluating DA-3031 (PEG-G-CSF) to Filgrastim (Dong-A) in Healthy Volunteers

This study has been completed.
Sponsor:
Information provided by:
Dong-A ST Co., Ltd.
ClinicalTrials.gov Identifier:
NCT00959777
First received: August 13, 2009
Last updated: September 29, 2014
Last verified: September 2014

August 13, 2009
September 29, 2014
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Complete list of historical versions of study NCT00959777 on ClinicalTrials.gov Archive Site
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Pharmacokinetic/Pharmacodynamic (PK/PD) Study Evaluating DA-3031 (PEG-G-CSF) to Filgrastim (Dong-A) in Healthy Volunteers
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The safety, tolerability, and pharmacokinetics(PK)/pharmacodynamics (PD) of DA-3031 (PEG-G-CSF) following a single dose delivered by subcutaneous (SC) injection were investigated in healthy volunteers. PK/PD of filgrastim (Dong-A) following repeated dose delivered by SC injection were investigated in healthy volunteers. PK/PD from a single dose of DA-3031 and repeated dose of filgrastim (Dong-A) were compared.

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Interventional
Phase 1
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Healthy Volunteers
  • Drug: DA-3031
  • Drug: Filgrastim
  • Experimental: DA-3031
    Intervention: Drug: DA-3031
  • Active Comparator: filgrastim
    Intervention: Drug: Filgrastim
Ahn LY, Shin KH, Lim KS, Kim TE, Jeon H, Yoon SH, Cho JY, Shin SG, Jang IJ, Yu KS. Relationship between absolute neutrophil count profiles and pharmacokinetics of DA-3031, a pegylated granulocyte colony-stimulating factor (pegylated-G-CSF): a dose block-randomized, double-blind, dose-escalation study in healthy subjects. Clin Drug Investig. 2013 Nov;33(11):817-24.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
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Inclusion Criteria:

  • Healthy males subjects, 20-40 years inclusive
  • weight 60-75 kg inclusive and Ideal Body Weight (IBW) between -15% and +15% inclusive
  • Written informed consent given
  • Willing and able to comply with the requirements of the protocol

Exclusion Criteria:

  • Hypersensitivity to drugs(aspirin, antibiotics and so on)
  • History or presence of any clinically significant liver or kidney disease, gastrointestinal, cardiovascular, respiratory, endocrinal, musculoskeletal, neurologic/psychiatric, hematological, oncological pathology
  • Have a history of drug abuse, or show positive for drug abuse at urine screening
  • Have participated in another clinical study within 2 months prior to entering inth the study
  • Have been persistently drinking alcohol or can not stop drinking alcohol during the study
  • Smokers whose average smoke for last 3 months is more than 10 cigarettes/day
  • Are considered ineligible by the investigator due to clinical laboratory results or any other relevant reasons
Male
20 Years to 40 Years
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Contact information is only displayed when the study is recruiting subjects
Korea, Republic of
 
NCT00959777
DA3031_NP_I
No
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Dong-A ST Co., Ltd.
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Dong-A ST Co., Ltd.
September 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP