Pharmacokinetic/Pharmacodynamic (PK/PD) Study Evaluating DA-3031 (PEG-G-CSF) to Filgrastim (Dong-A) in Healthy Volunteers (NCT00959777)

Study summary

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.

Conditions studied

Healthy Volunteers

In context

Lead sponsor

Dong-A ST Co., Ltd. is the lead sponsor of 122 studies on the registry; 9 are open to participants now.

Counted across the registry records on this site, refreshed daily.

Who can participate

Ages eligible: 20 Years to 40 Years
Sexes eligible: 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

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

Study design

Phase: Phase 1

Study arms

Experimental
DA-3031
Drug: DA-3031
Active comparator
filgrastim
Drug: Filgrastim

Interventions

DrugDA-3031
DrugFilgrastim

Study locations

1 site

Clinical Trials center, Clinical Research institute, Seoul National University Hospital
Seoul, Yonggon-Dong, Chongono-Gu 110-744, Korea, Republic of

References and documents

Publications

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. doi: 10.1007/s40261-013-0130-9. PubMed 24078278 ↗

Updates

Tracking since Sep 25, 2026

No changes since tracking began. The registry record was last updated on Oct 1, 2014, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗

Registry details

Key details

Study ID: NCT00959777
Lead sponsor: Dong-A ST Co., Ltd.
First posted: Aug 17, 2009
Last update: Oct 1, 2014

Oversight

Data monitoring committee: No

View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Sep 2014. You cannot join it, but the record below documents what was studied.

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Discussion

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