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

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

Condition Intervention Phase
Healthy Volunteers Drug: DA-3031 Drug: Filgrastim Phase 1

Study Type: Interventional

Resource links provided by NLM:

Further study details as provided by Dong-A ST Co., Ltd.:

Arms Assigned Interventions
Experimental: DA-3031 Drug: DA-3031
Active Comparator: filgrastim Drug: Filgrastim


Ages Eligible for Study:   20 Years to 40 Years   (Adult)
Sexes Eligible for Study:   Male

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
  Contacts and Locations
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Please refer to this study by its identifier: NCT00959777

Korea, Republic of
Clinical Trials center, Clinical Research institute, Seoul National University Hospital
Seoul, Yonggon-Dong, Chongono-Gu, Korea, Republic of, 110-744
Sponsors and Collaborators
Dong-A ST Co., Ltd.
  More Information

Publications automatically indexed to this study by Identifier (NCT Number): Identifier: NCT00959777     History of Changes
Other Study ID Numbers: DA3031_NP_I
Study First Received: August 13, 2009
Last Updated: September 29, 2014

Additional relevant MeSH terms:
Adjuvants, Immunologic
Immunologic Factors
Physiological Effects of Drugs processed this record on August 18, 2017