Status:
COMPLETED
Pharmacokinetic/Pharmacodynamic (PK/PD) Study Evaluating DA-3031 (PEG-G-CSF) to Filgrastim (Dong-A) in Healthy Volunteers
Lead Sponsor:
Dong-A ST Co., Ltd.
Conditions:
Healthy Volunteers
Eligibility:
MALE
20-40 years
Phase:
PHASE1
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...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
Trial Type :
INTERVENTIONAL
End Date :
Estimated Enrollment :
Patients enrolled
Trial Details
Trial ID
NCT00959777
Last Update
October 1 2014
Active Locations (1)
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1
Clinical Trials center, Clinical Research institute, Seoul National University Hospital
Seoul, Yonggon-Dong, Chongono-Gu, South Korea, 110-744