Safety and Pharmacokinetic Characteristics of HD203 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

NCT01044836

Acronym

SPH

Enrollment

Registered

2010-01-08

Start date

2010-01-31

Completion date

2010-08-31

Last updated

2014-07-15

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

Conditions

Healthy

Keywords

Healthy volunteer

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.

Interventions

BIOLOGICALHD203

Injectable form

Study design

Allocation

RANDOMIZED

Intervention model

CROSSOVER

Primary purpose

BASIC_SCIENCE

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

Design outcomes

Primary

Measure	Time frame
Etanercept levels in blood	21 days

Countries

South Korea

Outcome results

None listed

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