Overview

Study Evaluating Single Doses Of SBI-087 In Japanese Subjects With Rheumatoid Arthritis

Status:
Completed
Trial end date:
2012-05-01
Target enrollment:
0
Participant gender:
All
Summary
The purpose of this study is to evaluate the safety and tolerability of single doses of SBI-087 in Japanese subjects with rheumatoid arthritis.
Phase:
Phase 1
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
Pfizer
Collaborator:
Emergent Product Development Seattle LLC
Criteria
Inclusion Criteria:

- Must meet American College of Rheumatology criteria for rheumatoid arthritis with
functional class I to III.

- Rheumatoid arthritis disease onset at >16 years of age and duration of disease at
least 6 months.

- Men or women of nonchildbearing potential (WONCBP), aged 20 to 70 years, inclusive at
the screening visit.

Exclusion Criteria:

- Any significant health problems other than rheumatoid arthritis.

- Treatment of greater than 10 mg of prednisone per day.

- Therapy with immunosuppressants within 6 months before study day 1