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Safety and Pharmacokinetic Characteristics of HD203 Liq. in Healthy Subjects

NCT01431404 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 44

Last updated 2013-07-08

No results posted yet for this 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.

Conditions

  • Healthy

Interventions

BIOLOGICAL

Etanercept (Enbrel)

prefilled syringe, SC

BIOLOGICAL

HD203

HD203, prefilled syringe, SC injection

Sponsors & Collaborators

  • Hanwha Chemical

    lead INDUSTRY

Principal Investigators

  • Kyung-Sang Yu, M.D., Ph.D. · Seoul National University Hospital

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
CROSSOVER

Eligibility

Min Age
20 Years
Max Age
40 Years
Sex
MALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2011-08-31
Primary Completion
2012-03-31
Completion
2013-06-30

Countries

  • South Korea

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01431404 on ClinicalTrials.gov