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Hospital","02115",{"type":55,"coordinates":159},[136,137],{"lat":137,"lon":136},[162],{"name":163,"role":40,"phone":164,"phoneExt":32,"email":165},"Oliva Gabriel","617-525-8250","ogabriel@bwh.harvard.edu",{"facility":167,"status":48,"city":168,"state":169,"zip":170,"country":52,"countryCode":53,"cosmosGeoPoint":171,"geoPoint":175,"contacts":176},"Oregon Health Sciences University","Portland","Oregon","97239",{"type":55,"coordinates":172},[173,174],-122.67621,45.52345,{"lat":174,"lon":173},[177],{"name":178,"role":40,"phone":179,"phoneExt":32,"email":180},"Issabell Melz","503-346-9701","melz@ohsu.edu",{"type":182,"investigatorFullName":32,"investigatorTitle":32,"investigatorAffiliation":32,"oldNameTitle":32,"oldOrganization":32},"SPONSOR","100531562","phase-1-study-of-single-doses-of-sbt777101-in-subjects-with-rheumatoid-arthritis-100531562",false,"NCT06201416","Study of Single Doses of SBT777101 in Subjects With Rheumatoid Arthritis","A Phase 1 Study to Evaluate the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics, and Activity of Single Ascending Doses of SBT777101 in Subjects With Rheumatoid Arthritis","Regulate-RA","Inclusion Criteria:\n\n* Body mass index (BMI) \\\u003C35 kg\u002Fm\\^2, inclusive\n* Adult-onset, moderate-to-severe rheumatoid arthritis (RA)\n* Moderate-to-severe active disease\n* b\u002FtsDMARD failure criterion (≥2)\n* Swollen joint count ≥4\n* Clinical and\u002For ultrasound evidence of synovitis\n* Prior inadequate response to or unable to tolerate available RA therapies\n* Stable doses of RA medications for at least 30 days\n* Use of highly effective methods of contraception\n\nExclusion Criteria:\n\n* Major surgery within 12 weeks prior to screening or planned within 12 months after dosing\n* Uncontrolled cardiovascular, pulmonary, renal, hepatic, endocrine, or gastrointestinal disease\n* Recurrent infections or active infection\n* Active or untreated latent tuberculosis\n* Primary or secondary immunodeficiency\n* History of or current inflammatory joint disease other than RA","ALL","18 Years","70 Years",{"count":195,"type":196},48,"ESTIMATED","INTERVENTIONAL",[199],"PHASE1","This study will test the safety and effects of SBT777101 when given as a single dose to subjects with rheumatoid arthritis. 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