Skip to main content
OpenTrials
Completed

NCT Number: NCT00959777

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

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Healthy Volunteers

Age range

20 year–40 year

Sex eligibility

Male

Study type

Interventional

Phase

Phase 1

Primary location

Clinical Trials center, Clinical Research institute, Seoul National University Hospital

Seoul, Yonggon-Dong, Chongono-Gu, 110-744, South Korea

Who can participate

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

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

Treatment and study plan

DA-3031

Drug

Filgrastim

Drug

Sponsors and collaborators

Lead sponsor

Dong-A ST Co., Ltd.

Industry

Registry information

Important dates

First posted
Aug 17, 2009
Registry last updated
Oct 1, 2014

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.

Related clinical trials

Published trials that share one or more normalized conditions with this study.