Study of Single Doses of SBT777101 in Subjects With Rheumatoid Arthritis

Recruiting now · Phase 1

Conditions studied: Rheumatoid Arthritis

In brief

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.

Key facts

Study ID

NCT06201416

Run by

Sonoma Biotherapeutics, Inc.

People needed

48

Starts

2024-03-06

Expected to finish

2026-11-01

Last updated by the study team

2026-06-30

Who can join

Age: 18 and older, up to 70. Sex: any. Healthy volunteers: not accepted.

You 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
• 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

You may not qualify 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

Where it is running

• Mayo Clinic — Scottsdale, Arizona, United States (enrolling)
• UCSF Medical Center — San Francisco, California, United States (enrolling)
• Stanford Medical Center — Stanford, California, United States (enrolling)
• University of Colorado — Aurora, Colorado, United States (enrolling)
• Northwestern University — Chicago, Illinois, United States (enrolling)
• Tufts University — Boston, Massachusetts, United States (enrolling)
• Massachusetts General Hospital — Boston, Massachusetts, United States (enrolling)
• Brigham and Women's Hospital — Boston, Massachusetts, United States (enrolling)
• Oregon Health Sciences University — Portland, Oregon, United States (enrolling)

Full record on ClinicalTrials.gov

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