Pharmacokinetics and Pharmacodynamics of a Novel Pegylated Recombinant Human Granulocyte-Colony Stimulating Factor

NCT ID: NCT00969826

Last Updated: 2011-01-11

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 38 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2008-09-30
• Study Completion Date: 2009-09-30

Brief Summary

This study is a four arm, parallel study.

Ten were administered a single subcutaneous administration of 30, 100 and 300 μg/kg of GCPGC or placebo for each group (active:placebo=8:2). Eight were administered a single subcutaneous administration of 100 μg/kg of Neulasta (an active comparator).

Detailed Description

Eligibility for participation of this study was determined from demographic information, medical history, physical examination, electrocardiogram (ECG) and clinical laboratory tests within 3 weeks before study drug administration. Subjects suitable for this study were admitted to the Clinical Trials Center, Seoul National University Hospital on the day before dosing, and they were overnight-fasted from 10 p.m. of Day -1. Subjects were dosed study drug via subcutaneous around at 9 a.m. of Day 1. Subjects performed scheduled procedures including clinical laboratory tests, electrocardiograms and pharmacokinetic and pharmacodynamic samplings. Subjects were discharged on Day 8, and visited Clinical Trials Center on Day 9, Day 11 and Day 14. Study participation was terminated on post-study visit (Day 20 - 22).

Conditions

Healthy

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

GCPGC 30 μg/kg

Ten volunteers were administered GCPGC 30 μg/kg or placebo (active:placebo=8:2)

Group Type: EXPERIMENTAL

GCPGC, Neulasta, Placebo

Intervention Type: DRUG

A single subcutaneous administration of GCPGC 30 μg/kg, GCPGC 100 μg/kg, GCPGC 300 μg/kg, placebo or Neulasta 100 μg/kg

GCPGC 100 μg/kg

Ten volunteers were administered GCPGC 100 μg/kg or placebo (active:placebo=8:2)

Group Type: EXPERIMENTAL

GCPGC, Neulasta, Placebo

Intervention Type: DRUG

A single subcutaneous administration of GCPGC 30 μg/kg, GCPGC 100 μg/kg, GCPGC 300 μg/kg, placebo or Neulasta 100 μg/kg

GCPGC 300 μg/kg

Ten volunteers would be administered GCPGC 300 μg/kg or placebo (active:placebo=8:2)

Group Type: EXPERIMENTAL

GCPGC, Neulasta, Placebo

Intervention Type: DRUG

A single subcutaneous administration of GCPGC 30 μg/kg, GCPGC 100 μg/kg, GCPGC 300 μg/kg, placebo or Neulasta 100 μg/kg

Neulasta 100 μg/kg

Eight volunteers were administered Neulasta 100 μg/kg

Group Type: EXPERIMENTAL

GCPGC, Neulasta, Placebo

Intervention Type: DRUG

A single subcutaneous administration of GCPGC 30 μg/kg, GCPGC 100 μg/kg, GCPGC 300 μg/kg, placebo or Neulasta 100 μg/kg

Interventions

GCPGC, Neulasta, Placebo

A single subcutaneous administration of GCPGC 30 μg/kg, GCPGC 100 μg/kg, GCPGC 300 μg/kg, placebo or Neulasta 100 μg/kg

Intervention Type: DRUG

Other Intervention Names

Neulasta® (Amgen, USA; active comparator)

Eligibility Criteria

Inclusion Criteria

• Age: Between 20 to 40 years of age, inclusive (Age based on the date to give the informed consent)
• Weight: Between 60 - 75 kg, within ±20% of ideal body weight
• Normal clinical laboratory findings, especially for ANC value between 2000 to 7500, inclusive
• Subject who are reliable and willing to make themselves available during the study period, are willing to follow the study protocol, and give their written informed consent voluntarily

Exclusion Criteria

• History of hypersensitive reaction to medication (aspirin, antibiotics)
• History of significant clinical illness needs medical caution, including cardiovascular, immunologic, hematologic, neuropsychiatric, respiratory, gastrointestinal, hepatic, or renal disease or other chronic disease
• History or evidence of drug abuse
• Use any prescriptive medication, Korean traditional medication not considered acceptable by the clinical investigator during the last 14 days period before first dosing, or use any OTC medication not considered acceptable by the clinical investigator during the last 7 days period before first dosing (if used medication is considered acceptable by investigator, patients can be included)
• Participation in clinical trials of any drug within 60 days prior to the participation of the study
• Donation of whole blood within 60 days or a unit of blood within 30 days prior to the start of study
• Judged to be inappropriate for the study by the investigator

• Minimum Eligible Age: 20 Years
• Maximum Eligible Age: 40 Years
• Eligible Sex: MALE
• Accepts Healthy Volunteers: Yes

Sponsors

Green Cross Corporation

INDUSTRY

Sponsor Role: collaborator

Seoul National University Hospital

OTHER

Sponsor Role: lead

Responsible Party

Clinical Research Team / Development Division Associate Director

Principal Investigators

Kyung-Sang Yu, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Seoul National University College of Medicine and Hospital

Locations

Clinical Trials Center, Seoul National University Hospital

Seoul, , South Korea

Countries

South Korea

Other Identifiers

SNUCPT08_GCPGC

Identifier Type: -

Identifier Source: org_study_id