CompletedNCT01894412Updated Jul 14, 2016

Safety and Pharmacokinetic Characteristics of HD203 Liquid in Healthy Male Volunteers

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 2016-07-14.

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

Phase: Phase 1
Study type: Interventional
Enrollment: 48
Allocation: Randomized
Ages: 20 Years to 40 Years
Sex: Male

Study 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

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

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: 48 participants (actual)

Study arms

Experimental
HD 203
prefilled syringe
Biological: Etanercept (Enbrel) · Biological: HD203
Active comparator
Enbrel
prefilled syringe
Biological: Etanercept (Enbrel) · Biological: HD203

Interventions

BiologicalEtanercept (Enbrel)
BiologicalHD203

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 56 days

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 14, 2016, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗

Registry details

Key details

Study ID: NCT01894412
Lead sponsor: Hanwha Chemical
Responsible party: Sponsor
First posted: Jul 10, 2013
Start date: Jul 2013
Primary completion: Dec 2015
Completion: Dec 2015
Last update: Jul 14, 2016

Study contacts

Kyung-Sang Yu

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 2016. You cannot join it, but the record below documents what was studied.

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Discussion

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