Study of Single Doses of SBT777101 in Subjects With Rheumatoid Arthritis
ConditionRheumatoid 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 groupsSponsors and collaborators
Source ClinicalTrials.gov