NCT06201416RecruitingPhase 1
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
Source: ClinicalTrials.gov · Last updated 30 Jun 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Recruiting
- Phase (registry)
- Phase 1
- Study type
- Interventional
- Enrollment
- 48 (estimated)
- First submitted
- 1 Jan 2024
- Start date
- 6 Mar 2024
- Primary completion date
- 30 Nov 2026
- Lead sponsor
- Sonoma Biotherapeutics, Inc.
- Diseases
- Rheumatoid arthritis
- NCT number
- NCT06201416
What you commit to
- Study type: Interventional · Phase 1
- Planned participants: 48
- From 6 Mar 2024 to the primary completion date, 30 Nov 2026
- 9 sites in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Major surgery within 12 weeks prior to screening or planned within 12 months after dosing
Other illness
- 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
Other
- Primary or secondary immunodeficiency
Who the study is looking for
- 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
Age in the registry: 18 years to 70 years · Sex: All · Does not accept healthy volunteers
Sites (9)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| University of Colorado Coordinator of this site? Confirm its status | Aurora | United States | Recruiting |
| Massachusetts General Hospital Coordinator of this site? Confirm its status | Boston | United States | Recruiting |
| Brigham and Women's Hospital Coordinator of this site? Confirm its status | Boston | United States | Recruiting |
| Tufts University Coordinator of this site? Confirm its status | Boston | United States | Recruiting |
| Northwestern University Coordinator of this site? Confirm its status | Chicago | United States | Recruiting |
| Oregon Health Sciences University Coordinator of this site? Confirm its status | Portland | United States | Recruiting |
| UCSF Medical Center Coordinator of this site? Confirm its status | San Francisco | United States | Recruiting |
| Mayo Clinic Coordinator of this site? Confirm its status | Scottsdale | United States | Recruiting |
| Stanford Medical Center Coordinator of this site? Confirm its status | Stanford | United States | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.