NCT01431404

Brief Summary

The purpose of this study is compare the safety and pharmacokinetic characteristics of HD203 liquid with those of etanercept (enbrel) prefilled injection after subcutaneous injection.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
44

participants targeted

Target at P50-P75 for phase_1 healthy

Timeline
Completed

Started Aug 2011

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

August 1, 2011

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

September 5, 2011

Completed
4 days until next milestone

First Posted

Study publicly available on registry

September 9, 2011

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2012

Completed
1.3 years until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2013

Completed
Last Updated

July 8, 2013

Status Verified

July 1, 2013

Enrollment Period

7 months

First QC Date

September 5, 2011

Last Update Submit

July 3, 2013

Conditions

Healthy

Outcome Measures

Primary Outcomes (1)

  • Area under the concentration-time curve of the analyte in plasma over the time interval from 0 extrapolated to infinity

    up to 49days

Study Arms (2)

Enbrel, prefilled syringe

ACTIVE COMPARATOR
Biological: Etanercept (Enbrel)

HD203, prefilled syringe

EXPERIMENTAL
Biological: HD203

Interventions

Etanercept (Enbrel)BIOLOGICAL

prefilled syringe, SC

Enbrel, prefilled syringe
HD203BIOLOGICAL

HD203, prefilled syringe, SC injection

HD203, prefilled syringe

Eligibility Criteria

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

You may qualify if:

  • to 40 years of healthy volunteers
  • Weight over 55kg
  • Subject who signed on ICF

You may not qualify if:

  • Subject who had been treated with Etanercept before

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Seoul National University Hospital

Seoul, South Korea

Location

MeSH Terms

Interventions

Etanercept

Intervention Hierarchy (Ancestors)

Immunoglobulin Fc FragmentsImmunoglobulin FragmentsPeptide FragmentsPeptidesAmino Acids, Peptides, and ProteinsImmunoglobulin Constant RegionsImmunoglobulinsImmunoproteinsBlood ProteinsProteinsSerum GlobulinsGlobulinsReceptors, Tumor Necrosis FactorReceptors, CytokineReceptors, ImmunologicReceptors, Cell SurfaceMembrane Proteins

Study Officials

  • Kyung-Sang Yu, M.D., Ph.D.

    Seoul National University Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
CROSSOVER
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 5, 2011

First Posted

September 9, 2011

Study Start

August 1, 2011

Primary Completion

March 1, 2012

Study Completion

June 1, 2013

Last Updated

July 8, 2013

Record last verified: 2013-07

Locations

KR(1)