Study of Single Doses of SBT777101 in Subjects With Rheumatoid Arthritis

Trial statusRecruiting
Trial phasePhase 1
Trial typeInterventional
Biological sexAll
Age18-70
SponsorSonoma Biotherapeutics, Inc.

About this trial

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.

Eligibility criteria

Qualifiers

Body mass index (BMI) <35 kg/m², inclusive

Adult-onset, moderate-to-severe rheumatoid arthritis (RA)

Moderate-to-severe active disease

b/tsDMARD failure criterion (≥2)

Disqualifiers

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

Trial design

Treatments tested in this trial

  • SBT777101

Treatment groups

48 Participants
are divided into 4 treatment groups

Locations

9
Arizona
Mayo Clinic85259, Scottsdale United States
California
UCSF Medical Center94143, San Francisco United States
Stanford Medical Center94305, Stanford United States
Colorado
University of Colorado80045, Aurora United States

Sponsors and collaborators

Sonoma Biotherapeutics, Inc.

Lead sponsor