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

• Status: Completed
• Trial end date: 1969-12-31
• Target enrollment: 0
• Participant gender: Male

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.

• Phase: Phase 1

Details

• Lead Sponsor: Dong-A ST Co., Ltd.
• Treatments: Lenograstim

Criteria

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