Study Evaluating Enbrel Drug Levels in Healthy Male Chinese Subjects

Wyeth

Status and phase: Completed; Phase 1

Conditions: Healthy Subjects

Treatments: Drug: Etanercept

Study type: Interventional

Funder types: Industry

Identifiers

NCT00705042

0881A1-1110

Details and patient eligibility

About

The purpose of this study is to evaluate the Pharmacokinetics (PK) and safety and tolerability of etanercept, 25 and 50 mg, administered as a single dose to healthy male Chinese subjects.

Enrollment: 60 patients

Sex: Male

Ages: 18 to 45 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

Healthy male Chinese subjects, ages 18 to 45. BMI in the range of 18 to 30 kg/m2 and weight greater than or equal to 50 kg.

Exclusion criteria

Active tuberculosis (TB) or history of TB. Serious infection (associated with hospitalization and/or antibiotics) within 1 month before study drug administration.

History of protein drug hypersensitivity.

Trial design

Primary purpose: Basic Science

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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60 participants in 2 patient groups

A

Experimental group

Description:

25 mg

Treatment:

Drug: Etanercept

B

Experimental group

Description:

50 mg

Treatment:

Drug: Etanercept