RecruitingPhase 1NCT06201416

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


Sponsor

Sonoma Biotherapeutics, Inc.

Enrollment

24 participants

Start Date

Mar 6, 2024

Study Type

INTERVENTIONAL

Conditions

Summary

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.


Eligibility

Min Age: 18 YearsMax Age: 70 Years

Plain Language Summary

Simplified for easier understanding

This early-phase trial tests a new single-dose treatment (SBT777101) for rheumatoid arthritis (RA) — a condition where the immune system attacks the joints, causing pain and swelling — in patients who have not had enough relief from existing treatments. **You may be eligible if...** - You have been diagnosed with moderate-to-severe rheumatoid arthritis in adulthood - Your RA is currently active (painful, swollen joints) - Your RA medications have been at a stable dose for at least 30 days - Previous RA treatments have not worked well enough or caused side effects you couldn't tolerate - Your BMI is below 35 - You agree to use effective contraception during the study **You may NOT be eligible if...** - You had major surgery in the last 12 weeks or plan surgery in the next year - You have uncontrolled heart, lung, kidney, or liver disease - You have an active infection or a history of repeated infections - You have untreated latent tuberculosis (TB) - You have a weakened immune system or an immune deficiency condition - You have another type of inflammatory joint disease (other than RA) Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

BIOLOGICALSBT777101

Experimental treatment


Locations(8)

Mayo Clinic

Scottsdale, Arizona, United States

UCSF Medical Center

San Francisco, California, United States

Stanford Medical Center

Stanford, California, United States

University of Colorado

Aurora, Colorado, United States

Northwestern University

Chicago, Illinois, United States

Tufts University

Boston, Massachusetts, United States

Massachusetts General Hospital

Boston, Massachusetts, United States

Brigham and Women's Hospital

Boston, Massachusetts, United States

View Full Details on ClinicalTrials.gov

For the most up-to-date information, visit the official listing.

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NCT06201416


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