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

Phase 1

Completed

• Conditions: Healthy Volunteers
• Interventions: Drug: DA-3031; Drug: Filgrastim

• Registration Number: NCT00959777
• Lead Sponsor: Dong-A ST Co., Ltd.

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2009-08-13
• Study First Submitted QC: 2009-08-14
• Study First Posted: 2009-08-17
• Status Verified: 2014-09
• Last Update Submitted: 2014-09-29
• Last Update Posted: 2014-10-01

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Male
• Target Recruitment: Not specified

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
DA-3031	DA-3031	-
filgrastim	Filgrastim	-

Trial Locations

Locations (1)

Clinical Trials center, Clinical Research institute, Seoul National University Hospital; 🇰🇷 Seoul, Yonggon-Dong, Chongono-Gu, Korea, Republic of