NCT00969826

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).

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
38

participants targeted

Target at P50-P75 for phase_1 healthy

Timeline
Completed

Started Sep 2008

Longer than P75 for phase_1 healthy

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2008

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2009

Completed
8 months until next milestone

First Submitted

Initial submission to the registry

August 29, 2009

Completed
3 days until next milestone

First Posted

Study publicly available on registry

September 1, 2009

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2009

Completed
Last Updated

January 11, 2011

Status Verified

January 1, 2011

Enrollment Period

4 months

First QC Date

August 29, 2009

Last Update Submit

January 9, 2011

Conditions

Healthy

Keywords

GCPGCPharmacokineticsPharmacodynamics

Outcome Measures

Primary Outcomes (1)

  • Blood concentration of pegfilgrastim for pharmacokinetics

    pre-dose, 3, 6, 9, 12, 24(2d), 36, 48(3d), 72(4d), 96(5d), 120(6d), 144(7d), 168(8d), 192h(9d), 240(11d), 312(14d)

Secondary Outcomes (2)

  • Absolute Neutrophil Count (ANC)

    pre-dose, 6, 12, 24(2d), 48(3d), 72(4d), 96(5d), 120(6d), 144(7d), 168(8d), 192h(9d), 240(11d), 312(14d)

  • CD34+ Cell count

    pre-dose, 6, 12, 24(2d), 48(3d), 72(4d), 96(5d), 120(6d), 144(7d), 168(8d), 192h(9d), 240(11d), 312(14d)

Study Arms (4)

GCPGC 30 μg/kg

EXPERIMENTAL

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

Drug: GCPGC, Neulasta, Placebo

GCPGC 100 μg/kg

EXPERIMENTAL

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

Drug: GCPGC, Neulasta, Placebo

GCPGC 300 μg/kg

EXPERIMENTAL

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

Drug: GCPGC, Neulasta, Placebo

Neulasta 100 μg/kg

EXPERIMENTAL

Eight volunteers were administered Neulasta 100 μg/kg

Drug: GCPGC, Neulasta, Placebo

Interventions

GCPGC, Neulasta, PlaceboDRUG

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

Also known as: Neulasta® (Amgen, USA; active comparator)
GCPGC 100 μg/kgGCPGC 30 μg/kgGCPGC 300 μg/kgNeulasta 100 μg/kg

Eligibility Criteria

Age20 Years - 40 Years
Sexmale
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Clinical Trials Center, Seoul National University Hospital

Seoul, 110-744, South Korea

Location

MeSH Terms

Interventions

pegfilgrastim

Study Officials

  • Kyung-Sang Yu, MD, PhD

    Seoul National University College of Medicine and Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

August 29, 2009

First Posted

September 1, 2009

Study Start

September 1, 2008

Primary Completion

January 1, 2009

Study Completion

September 1, 2009

Last Updated

January 11, 2011

Record last verified: 2011-01

Locations

KR(1)