NCT01044836

Brief Summary

The purpose of this study is compare the safety and pharmacokinetic characteristics of HD203 with those of etanercept after subcutaneous injection in healthy male volunteers.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
42

participants targeted

Target at P50-P75 for phase_1 healthy

Timeline
Completed

Started Jan 2010

Typical duration 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

January 1, 2010

Completed
4 days until next milestone

First Submitted

Initial submission to the registry

January 5, 2010

Completed
3 days until next milestone

First Posted

Study publicly available on registry

January 8, 2010

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2010

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2010

Completed
Last Updated

July 15, 2014

Status Verified

July 1, 2014

Enrollment Period

6 months

First QC Date

January 5, 2010

Last Update Submit

July 13, 2014

Conditions

Healthy

Keywords

Healthy volunteer

Outcome Measures

Primary Outcomes (1)

  • Etanercept levels in blood

    21 days

Study Arms (1)

Etanercept

EXPERIMENTAL
Biological: HD203

Interventions

HD203BIOLOGICAL

Injectable form

Etanercept

Eligibility Criteria

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

You may qualify if:

  • to 40 years of healthy volunteers

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Seoul National University Hospital

Seoul, South Korea

Location

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
BASIC SCIENCE
Intervention Model
CROSSOVER
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 5, 2010

First Posted

January 8, 2010

Study Start

January 1, 2010

Primary Completion

July 1, 2010

Study Completion

August 1, 2010

Last Updated

July 15, 2014

Record last verified: 2014-07

Locations

KR(1)