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

Status
Completed
Phases
Phase 1
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT00959777
Enrollment
Unknown
Registered
2009-08-17
Start date
Unknown
Completion date
Unknown
Last updated
2014-10-01

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Healthy Volunteers

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.

Interventions

DRUGDA-3031
DRUGFilgrastim

Sponsors

Dong-A ST Co., Ltd.
Lead SponsorINDUSTRY

Eligibility

Sex/Gender
MALE
Age
20 Years to 40 Years

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

Countries

South Korea

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026