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Safety and Pharmacokinetic Characteristics of HD203 Liquid in Healthy Male Volunteers

H

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

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)

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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