Safety and Pharmacokinetic Characteristics of HD203 Liquid in Healthy Male Volunteers

A Randomized, Double-blind, Single-dosing, Crossover Study to Compare the Safety and Pharmacokinetic Characteristics of HD203 25 mg With Those of Enbrel® Injection 25 mg After Subcutaneous Injection in Healthy Male Volunteers

Status

Completed

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01894412

Enrollment

Registered

2013-07-10

Start date

2013-07-31

Completion date

2015-12-31

Last updated

2016-07-14

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Healthy

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

Interventions

BIOLOGICALEtanercept (Enbrel)

BIOLOGICALHD203

Study design

Allocation

RANDOMIZED

Intervention model

CROSSOVER

Primary purpose

TREATMENT

Masking

QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender

MALE

Age

20 Years to 40 Years

Healthy volunteers

Yes

Inclusion criteria

* 20 to 40 years of healthy volunteers

Exclusion criteria

* Subject who had been treated with Etanercept before

Design outcomes

Primary

Measure	Time frame
Area under the concentration-time curve of the analyte in plasma over the time interval from 0 extrapolated to infinity	up to 56 days

Countries

South Korea

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026