Actively Recruiting

Phase 1
Age: 18Years - 70Years
All Genders
NCT06201416

Study of Single Doses of SBT777101 in Subjects With Rheumatoid Arthritis

Led by Sonoma Biotherapeutics, Inc. · Updated on 2026-04-20

24

Participants Needed

8

Research Sites

138 weeks

Total Duration

On this page

AI-Summary

What this Trial 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.

CONDITIONS

Official Title

Study of Single Doses of SBT777101 in Subjects With Rheumatoid Arthritis

Who Can Participate

Age: 18Years - 70Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Body mass index (BMI) less than 35 kg/m2, inclusive
  • Adult-onset, moderate-to-severe rheumatoid arthritis
  • Moderate-to-severe active disease
  • Clinical and/or ultrasound evidence of synovitis
  • Prior inadequate response to or intolerance of available rheumatoid arthritis therapies
  • Stable doses of rheumatoid arthritis medications for at least 30 days
  • Use of highly effective contraception methods
Not Eligible

You will not qualify if you...

  • 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 or current inflammatory joint disease other than rheumatoid arthritis

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 8 locations

1

Mayo Clinic

Scottsdale, Arizona, United States, 85259

Actively Recruiting

2

UCSF Medical Center

San Francisco, California, United States, 94143

Actively Recruiting

3

Stanford Medical Center

Stanford, California, United States, 94305

Actively Recruiting

4

University of Colorado

Aurora, Colorado, United States, 80045

Actively Recruiting

5

Northwestern University

Chicago, Illinois, United States, 60611

Actively Recruiting

6

Tufts University

Boston, Massachusetts, United States, 02111

Actively Recruiting

7

Massachusetts General Hospital

Boston, Massachusetts, United States, 02114

Actively Recruiting

8

Brigham and Women's Hospital

Boston, Massachusetts, United States, 02115

Actively Recruiting

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Research Team

S

Sabrina Fox-Bosetti, MPH

CONTACT

J

Jason Do

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

NON_RANDOMIZED

Model

SEQUENTIAL

Primary Purpose

TREATMENT

Number of Arms

3

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Study of Single Doses of SBT777101 in Subjects With Rheumatoid Arthritis | DecenTrialz