Study of Single Doses of SBT777101 in Subjects With Rheumatoid Arthritis

Summary

This study will test the safety and effects of SBT777101 when given as a single dose to subjects with rheumatoid arthritis. It is the first study of this treatment being done in humans. Increasing dose levels will be given after the safety at lower dose levels is shown.

Eligibility

Inclusion Criteria:

* Body mass index (BMI) \<35 kg/m\^2, inclusive
* Adult-onset, moderate-to-severe rheumatoid arthritis (RA)
* Moderate-to-severe active disease
* Clinical and/or ultrasound evidence of synovitis
* Prior inadequate response to or unable to tolerate available RA therapies
* Stable doses of RA medications for at least 30 days
* Use of highly effective methods of contraception

Exclusion Criteria:

* Major surgery within 12 weeks prior to screening or planned within 12 months after dosing
* Uncontrolled cardiovascular, pulmonary, renal, hepatic, endocrine, or gastrointestinal disease
* Recurrent infections or active infection
* Active or untreated latent tuberculosis
* Primary or secondary immunodeficiency
* History of or current inflammatory joint disease other than RA

Conditions2

Locations8 sites

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