Study Evaluating Etanercept 25mg or 50mg Administered Subcutaneously to Healthy Chinese Male Subjects

A Randomized, Open-Label, Single-Dose Administration, Parallel-Group Study of the Pharmacokinetics of Etanercept, 25mg or 50 mg, Administered Subcutaneously to Healthy Chinese Male Subjects

Status

Completed

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00502879

Enrollment

Unknown

Registered

2007-07-18

Start date

2007-07-31

Completion date

2007-08-31

Last updated

2007-12-06

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Healthy

Brief summary

The primary purpose of this study is to assess the pharmacokinetics of etanercept in healthy Chinese male subjects. Safety and tolerability data will also be obtained.

Interventions

DRUGEnbrel (etanercept)

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

MALE

Age

18 Years to 45 Years

Healthy volunteers

Yes

Inclusion criteria

1. Men, aged 18 to 45 years, of Chinese descent and living in China. 2. Body mass index in the range of 18.0 to 30.0 kg/meter squared and body weight equal to or greater than 50 kg. 3. Healthy as determined by the investigator on the basis of medical history, physical examination, clinical laboratory test results, vital signs, chest x-ray, and 12-lead electrocardiogram (ECG). 4. Have a high probability for compliance with and completion of the study.

Design outcomes

Primary

Measure	Time frame
To assess the pharmacokinetics of etanercept in healthy Chinese male subjects.	—

Countries

China

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026