CompletedNCT01431404Updated Jul 8, 2013

Safety and Pharmacokinetic Characteristics of HD203 Liq. in Healthy Subjects

A Phase 1 interventional study of Etanercept (Enbrel) and HD203 in Healthy, sponsored by Hanwha Chemical. Completed at 1 site in Korea, Republic of. Open to male participants aged 20 Years to 40 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2013-07-08.

Sponsored by Hanwha Chemical · Phase 1, Interventional, and Treatment

Phase: Phase 1
Study type: Interventional
Enrollment: 44
Allocation: Randomized
Ages: 20 Years to 40 Years
Sex: Male

Study 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.

Read the detailed description

A randomized, double-blind, single-dosing, crossover study to compare the safety and pharmacokinetic characteristics of HD203 Liquid 25 mg with those of Enbrel Prefilled® injection 25 mg after subcutaneous injection.

Conditions studied

Healthy

In context

Lead sponsor

Hanwha Chemical is the lead sponsor of 4 studies on the registry; none are open to participants now.

Counted across the registry records on this site, refreshed daily.

Who can participate

Ages eligible: 20 Years to 40 Years
Sexes eligible: Male
Accepts healthy volunteers: Yes

Inclusion criteria

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

Exclusion criteria

Exclusion Criteria:

Subject who had been treated with Etanercept before

Study design

Phase: Phase 1
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Crossover assignment
Masking: Quadruple (Participant, Care provider, Investigator, Outcomes assessor)
Enrollment: 44 participants (actual)

Study arms

Active comparator
Enbrel, prefilled syringe
Biological: Etanercept (Enbrel)
Experimental
HD203, prefilled syringe
Biological: HD203

Interventions

BiologicalEtanercept (Enbrel)
prefilled syringe, SC
BiologicalHD203
HD203, prefilled syringe, SC injection

What researchers measure

Primary outcomes

Area under the concentration-time curve of the analyte in plasma over the time interval from 0 extrapolated to infinity
Time frame: up to 49days

Study locations

1 site

Seoul National University Hospital
Seoul, Korea, Republic of

Updates

Tracking since Sep 25, 2026

No changes since tracking began. The registry record was last updated on Jul 8, 2013, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗

Registry details

Key details

Study ID: NCT01431404
Lead sponsor: Hanwha Chemical
Responsible party: Sponsor
First posted: Sep 9, 2011
Start date: Aug 2011
Primary completion: Mar 2012
Completion: Jun 2013
Last update: Jul 8, 2013

Study contacts

Kyung-Sang Yu, M.D., Ph.D.

principal investigator · Seoul National University Hospital

Oversight

Data monitoring committee: No

View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Jul 2013. You cannot join it, but the record below documents what was studied.

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Discussion

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