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: August 19, 2009
Last verified: August 2009
  Purpose

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

  Eligibility

Ages Eligible for Study:   20 Years to 40 Years
Genders Eligible for Study:   Male
Criteria

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00959777

Locations
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

No publications provided by Dong-A ST Co., Ltd.

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
ClinicalTrials.gov Identifier: NCT00959777     History of Changes
Other Study ID Numbers: DA3031_NP_I
Study First Received: August 13, 2009
Last Updated: August 19, 2009
Health Authority: Korea: Food and Drug Administration

Additional relevant MeSH terms:
Lenograstim
Adjuvants, Immunologic
Immunologic Factors
Physiological Effects of Drugs
Pharmacologic Actions

ClinicalTrials.gov processed this record on September 18, 2014