Safety and Pharmacokinetic Characteristics of HD203 Liq. in Healthy Subjects

Hanwha Chemical

Status and phase: Completed; Phase 1

Conditions: Healthy

Treatments: Biological: Etanercept (Enbrel); Biological: HD203

Study type: Interventional

Funder types: Industry

Identifiers

NCT01431404

EAGLE-I-11

Details and patient eligibility

About

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.

Full description

A randomized, double-blind, single-dosing, crossover study to compare the safety and pharmacokinetic characteristics of HD203 Liquid 25 mg with those of Enbrel Prefilled® injection 25 mg after subcutaneous injection.

Enrollment: 44 patients

Sex: Male

Ages: 20 to 40 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• 20 to 40 years of healthy volunteers
• Weight over 55kg
• Subject who signed on ICF

Exclusion criteria

• Subject who had been treated with Etanercept before

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Quadruple Blind

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44 participants in 2 patient groups

Enbrel, prefilled syringe

Active Comparator group

Treatment:

Biological: Etanercept (Enbrel)

HD203, prefilled syringe

Experimental group

Treatment:

Biological: HD203