Study to Compare the Safety and Pharmacokinetic Characteristics of LBEC0101 25 mg With Those of Enbrel®

LG Life Sciences

Status and phase: Completed; Phase 1

Conditions: Healthy

Treatments: Drug: Enbrel; Drug: LBEC0101

Study type: Interventional

Funder types: Industry

Identifiers

NCT01145950

LG-ECCL001

Details and patient eligibility

About

To compare the pharmacokinetic characteristic of LBEC0101 25mg with the active comparator, Enbrel® 25 mg.

Enrollment: 36 estimated patients

Sex: Male

Ages: 20 to 45 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• Healthy males, 20 to 45 years of age the moment of screening
• Body mass index is between 18.0 and 30.0 kg/m

Exclusion criteria

• The tuberculosis patient or latent tuberculosis patient
• Hypersensitivity response to the test and comparator drugs

Trial design

36 participants in 2 patient groups

Group 1

Experimental group

Treatment:

Drug: LBEC0101

Group 2

Experimental group

Treatment:

Drug: Enbrel