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

Pfizer

Status and phase: Completed; Phase 1

Conditions: Arthritis, Rheumatoid

Treatments: Drug: SBI-087

Study type: Interventional

Funder types: Industry

Identifiers

NCT00815906

B2261002

3227K1-1001

Details and patient eligibility

About

The purpose of this study is to evaluate the safety and tolerability of single doses of SBI-087 in Japanese subjects with rheumatoid arthritis.

Enrollment: 20 patients

Sex: All

Ages: 20 to 70 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)

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20 participants in 4 patient groups

SBI-087 0.15 mg IV

Experimental group

Treatment:

Drug: SBI-087

Drug: SBI-087

Drug: SBI-087

Drug: SBI-087

SBI-087 0.5 mg IV

Experimental group

Treatment:

Drug: SBI-087

Drug: SBI-087

Drug: SBI-087

Drug: SBI-087

SBI-087 100 mg SC

Experimental group

Treatment:

Drug: SBI-087

Drug: SBI-087

Drug: SBI-087

Drug: SBI-087

SBI-087 200 mg SC

Experimental group

Treatment:

Drug: SBI-087

Drug: SBI-087

Drug: SBI-087

Drug: SBI-087