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Study of Single Doses of SBT777101 in Subjects With Rheumatoid Arthritis

Sonoma Biotherapeutics, Inc. · NCT06201416

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Opens the official ClinicalTrials.gov record, with the study team’s contacts. Bored Studies doesn’t enroll anyone.

Key facts

Compensation
Not posted. Ask the study team before screening.
Who can join
Ages 18–70 · All sexes
Healthy volunteers
Not accepted (a condition is required)
Study type
Interventional · Phase 1
Target enrollment
48
US sites recruiting
9
Study start
March 6, 2024
Record last updated
June 30, 2026

Status re-checked against ClinicalTrials.gov within the last 12 hours.

What the study is about

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.

Being studied: SBT777101

Conditions: Rheumatoid Arthritis

Eligibility criteria

Copied from the official record. The study team makes the final decision at screening.

Show full criteria

Inclusion Criteria

  • 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 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

Recruiting US locations

  • Mayo Clinic

    Scottsdale, AZ 85259

    Site contact: Megan Hall · 401-301-6373 · hall.megan@mayo.edu

  • UCSF Medical Center

    San Francisco, CA 94143

    Site contact: Alex Carvidi · 628-206-2505 · alexcarvidi@ucsf.edu

  • Stanford Medical Center

    Stanford, CA 94305

    Site contact: Uma Vilas Ayachit · 925-860-8966

  • University of Colorado

    Aurora, CO 80045

    Site contact: Jennifer Seifert · 303-724-7541 · jennifer.seifert@cuanschutz.edu

  • Northwestern University

    Chicago, IL 60611

    Site contact: John Seagrist · 312-503-0565 · john.seagrist@northwestern.edu

  • Tufts University

    Boston, MA 02111

    Site contact: Andreas Klein · 617-636-5409 · tmncccr@tuftsmedicine.org

  • Massachusetts General Hospital

    Boston, MA 02114

    Site contact: Daniella Cook · 617-726-3914 · dtcook@mgh.edu

  • Brigham and Women's Hospital

    Boston, MA 02115

    Site contact: Oliva Gabriel · 617-525-8250 · ogabriel@bwh.harvard.edu

  • Oregon Health Sciences University

    Portland, OR 97239

    Site contact: Issabell Melz · 503-346-9701 · melz@ohsu.edu

Study contacts (from the official record)

  • Sabrina Fox-Bosetti, MPH · 415-992-6245 · clinicaloperations@sonomabio.com
  • Jason Do · 415-992-6245 · clinicaloperations@sonomabio.com
All arthritis studies in Arizona →
Study of Single Doses of SBT777101 in Subjects With Rheumatoid… (NCT06201416) | Bored Studies