Safety and Pharmacokinetic Characteristics of HD203 Liquid in Healthy Male Volunteers

Hanwha Chemical

Status and phase: Completed; Phase 1

Conditions: Healthy

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

Study type: Interventional

Funder types: Industry

Identifiers

NCT01894412

EAGLE-I-13

Details and patient eligibility

About

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

Enrollment: 48 patients

Sex: Male

Ages: 20 to 40 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• 20 to 40 years of healthy volunteers

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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48 participants in 2 patient groups

HD 203

Experimental group

Description:

prefilled syringe

Treatment:

Biological: HD203

Biological: Etanercept (Enbrel)

Enbrel

Active Comparator group

Description:

prefilled syringe

Treatment:

Biological: HD203

Biological: Etanercept (Enbrel)