What this study is
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.
What's being tested
- SBT777101
Intervention · BIOLOGICAL
Experimental treatment
Study details
- Official title
- A Phase 1 Study to Evaluate the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics, and Activity of Single Ascending Doses of SBT777101 in Subjects With Rheumatoid Arthritis
- Sponsor
- Sonoma Biotherapeutics, Inc.
- Conditions
- Rheumatoid Arthritis
- Enrolling
- 24 people
- Starts
- 2024-03-06
- Est. completion
- 2026-11
- Design
- Open-label, non-randomized, sequential groups, Phase 1
- Record
- View on ClinicalTrials.gov ↗
Who can join
Age 18 Years – 70 YearsSex ALLHealthy volunteers Not acceptedYou may qualify if
- Body mass index (BMI) <35 kg/m^2, inclusive
- Adult-onset, moderate-to-severe rheumatoid arthritis (RA)
- Moderate-to-severe active disease
- 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
You can't join if
- 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
Sign in and we'll check these against your records.Full criteria on ClinicalTrials.gov ↗
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Study locations (8)
8 open- Recruiting
UCSF Medical Center
San Francisco, California, United States
- Alex Carvidi · Contact628-206-2505alexcarvidi@ucsf.edu
Recruiting- Recruiting
University of Colorado
Aurora, Colorado, United States
- Jennifer Seifert · Contact303-724-7541jennifer.seifert@cuanschutz.edu
- Andrew Clauw · Contact303-724-7541andrew.clauw@cuanschutz.edu
- Larry Moreland, MD · Principal investigator
RecruitingNorthwestern University
Chicago, Illinois, United States
- John Seagrist · Contact312-503-0565john.seagrist@northwestern.edu
RecruitingTufts University
Boston, Massachusetts, United States
- Andreas Klein · Contact617-636-5409tmncccr@tuftsmedicine.org
RecruitingMassachusetts General Hospital
Boston, Massachusetts, United States
- Daniella Cook · Contact617-726-3914dtcook@mgh.edu
RecruitingBrigham and Women's Hospital
Boston, Massachusetts, United States
- Oliva Gabriel · Contact617-525-8250ogabriel@bwh.harvard.edu
Recruiting
Study team
Sponsor
Sonoma Biotherapeutics, Inc.
Study ID SBT777101-01
Study director
Sarah Baxter, MD, PhD
Sonoma Biotherapeutics, Inc.
Frequently asked questions
The sponsor hasn't published answers to common questions for this trial.