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

NCT00959777 | Completed Phase 1

• 1 other identifier: DA3031_NP_I
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

Brief 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

Healthy Volunteers

Study Arms (2)

DA-3031

EXPERIMENTAL

Drug: DA-3031

filgrastim

ACTIVE COMPARATOR

Drug: Filgrastim

Interventions

DA-3031 DRUG

DA-3031

Filgrastim DRUG

filgrastim

Eligibility Criteria

• Age: 20 Years - 40 Years
• Sex: male
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Dong-A ST Co., Ltd.: lead

Study Sites (1)

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

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

Location

Related Publications (2)

• Lee S, Hong KT, Jang IJ, Yu KS, Kang HJ, Oh J. Semimechanistic pharmacokinetic-pharmacodynamic model of tripegfilgrastim for pediatric patients after chemotherapy. CPT Pharmacometrics Syst Pharmacol. 2023 Sep;12(9):1319-1334. doi: 10.1002/psp4.13012. Epub 2023 Aug 9.

  PMID: 37559343 DERIVED

• 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.

  PMID: 24078278 DERIVED

MeSH Terms

Interventions

pegylated granulocyte colony-stimulating factor, human; Filgrastim

Intervention Hierarchy (Ancestors)

Granulocyte Colony-Stimulating Factor; Colony-Stimulating Factors; Glycoproteins; Glycoconjugates; Carbohydrates; Hematopoietic Cell Growth Factors; Cytokines; Intercellular Signaling Peptides and Proteins; Peptides; Amino Acids, Peptides, and Proteins; Proteins; Biological Factors

Study Design

• Study Type: interventional
• Phase: phase 1
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: August 13, 2009
• First Posted: August 17, 2009
• Last Updated: October 1, 2014

Record last verified: 2014-09

Locations

KR (1)