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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Study Classification

INTERVENTIONAL

Brief Summary

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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.

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Detailed Description

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Conditions

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Healthy Volunteers

Study Groups

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DA-3031

Group Type EXPERIMENTAL

DA-3031

Intervention Type DRUG

filgrastim

Group Type ACTIVE_COMPARATOR

Filgrastim

Intervention Type DRUG

Interventions

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DA-3031

Intervention Type DRUG

Filgrastim

Intervention Type DRUG

Eligibility Criteria

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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

Minimum Eligible Age

20 Years

Maximum Eligible Age

40 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

No