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

Dong-A ST

Status and phase

Completed

Phase 1

Conditions

Healthy Volunteers

Treatments

Drug: DA-3031

Drug: Filgrastim

Study type

Interventional

Funder types

Industry

Identifiers

NCT00959777

DA3031_NP_I

Details and patient eligibility

About

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.

Sex

Male

Ages

20 to 40 years old

Volunteers

No Healthy Volunteers

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