NCT00705042CompletedPhase 1
A Randomized, Open-Label, Single-Dose Administration, Parallel-Group, Multisite Study of the Pharmacokinetics of Etanercept, 25 or 50 mg, Administered Subcutaneously to Healthy Chinese Male Subjects
Wyeth is now a wholly owned subsidiary of Pfizer0 sites60 target enrollmentStarted: July 2008Last updated:
Conditions
Interventions
Drugs
Trial Snapshot
- Phase
- Phase 1
- Status
- Completed
- Sponsor
- Enrollment
- 60
- Primary Endpoint
- etanercept levels in the blood
Study Overview
Brief Summary
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Basic Science
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to 45 Years (Adult)
- Sex
- Male
- Accepts Healthy Volunteers
- Yes
Inclusion Criteria
- •Healthy male Chinese subjects, ages 18 to
- •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.
Arms & Interventions
A
Experimental
25 mg
Intervention: Etanercept (Drug)
B
Experimental
50 mg
Intervention: Etanercept (Drug)
Outcomes
Primary Outcomes
etanercept levels in the blood
Time Frame: 21 days
Secondary Outcomes
- Safety and tolerability of single doses of etanercept administered to healthy Chinese subjects(21 days)
Investigators
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