Tests SBT777101 single doses in adults with rheumatoid arthritis
Tests the safety of increasing single doses of SBT777101 in adults with rheumatoid arthritis.
Plain-language title generated from the registry record
Registry title: Study of Single Doses of SBT777101 in Subjects With Rheumatoid Arthritis
Key facts
- Where
- Aurora, Boston, Chicago, Portland, San Francisco, Scottsdale, and Stanford, United StatesSee the 9 sites
- Phase
- Phase 1
Could this be for you?
Answer for yourself. This is not a decision: only the study team can say whether you can take part.
- Are you between 18 and 70 years old?
Source: NCT06201416, who can take part
Where in United States
- University of ColoradoAurora, United StatesTaking people
- Brigham and Women's HospitalBoston, United StatesTaking people
- Massachusetts General HospitalBoston, United StatesTaking people
- Tufts UniversityBoston, United StatesTaking people
- Northwestern UniversityChicago, United StatesTaking people
- Oregon Health Sciences UniversityPortland, United StatesTaking people
- UCSF Medical CenterSan Francisco, United StatesTaking people
- Mayo ClinicScottsdale, United StatesTaking people
- Stanford Medical CenterStanford, United StatesTaking people
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- Sonoma Biotherapeutics, Inc.
- Trial code
- NCT06201416
- Record updated
- 30 June 2026
- Original description
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. Following completion of the initial single ascending dose cohorts, the study may evaluate alternative administration regimens of SBT777101, including split-dose administration. In the split-dose cohort, participants may receive two intravenous infusions of SBT777101 derived from a single manufacturing process, administered approximately 6 weeks apart. The study will continue to evaluate safety, tolerability, pharmacokinetics, pharmacodynamics, and preliminary clinical activity.Read full original descriptionShow less
A Phase 1 Study to Evaluate the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics, and Activity of Single Ascending Doses of SBT777101 in Subjects With Rheumatoid Arthritis
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. Following completion of the initial single ascending dose cohorts, the study may evaluate alternative administration regimens of SBT777101, including split-dose administration. In the split-dose cohort, participants may receive two intravenous infusions of SBT777101 derived from a single manufacturing process, administered approximately 6 weeks apart. The study will continue to evaluate safety, tolerability, pharmacokinetics, pharmacodynamics, and preliminary clinical activity.
Inclusion: Body mass index (BMI) <35 kg/m\^2, inclusive; Adult-onset, moderate-to-severe rheumatoid arthritis (RA); Moderate-to-severe active disease; b/tsDMARD failure criterion (≥2); Swollen joint count ≥4; 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: 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; History of or current inflammatory joint disease other than RA; Primary or secondary immunodeficiency.