NCT01894412

Brief Summary

The purpose of this study is to 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
48

participants targeted

Target at P50-P75 for phase_1 healthy

Timeline
Completed

Started Jul 2013

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

July 1, 2013

Completed
2 days until next milestone

First Submitted

Initial submission to the registry

July 3, 2013

Completed
7 days until next milestone

First Posted

Study publicly available on registry

July 10, 2013

Completed
2.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2015

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2015

Completed
Last Updated

July 14, 2016

Status Verified

July 1, 2016

Enrollment Period

2.4 years

First QC Date

July 3, 2013

Last Update Submit

July 12, 2016

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 56 days

Study Arms (2)

HD 203

EXPERIMENTAL

prefilled syringe

Biological: Etanercept (Enbrel)Biological: HD203

Enbrel

ACTIVE COMPARATOR

prefilled syringe

Biological: Etanercept (Enbrel)Biological: HD203

Interventions

Etanercept (Enbrel)BIOLOGICAL
EnbrelHD 203
HD203BIOLOGICAL
EnbrelHD 203

Eligibility Criteria

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

You may qualify if:

  • to 40 years of healthy volunteers

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

    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

July 3, 2013

First Posted

July 10, 2013

Study Start

July 1, 2013

Primary Completion

December 1, 2015

Study Completion

December 1, 2015

Last Updated

July 14, 2016

Record last verified: 2016-07

Locations

KR(1)