Safety and Pharmacokinetic Characteristics of HD203 in Healthy Male Volunteers (SPH)

Hanwha Chemical

Status and phase: Completed; Phase 1

Conditions: Healthy

Treatments: Biological: HD203

Study type: Interventional

Funder types: Industry

Identifiers

NCT01044836

EAGLE-I-09

Details and patient eligibility

About

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.

Enrollment: 42 patients

Sex: Male

Ages: 20 to 40 years old

Volunteers: Accepts Healthy Volunteers

Inclusion and exclusion criteria

Inclusion Criteria:

• 20 to 40 years of healthy volunteers

Trial design

Primary purpose: Basic Science

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Quadruple Blind

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42 participants in 1 patient group

Etanercept

Experimental group

Treatment:

Biological: HD203