SBT777101 for Rheumatoid Arthritis
Study of Single Doses of SBT777101 in Subjects With Rheumatoid Arthritis
Recruiting
Phase 1
Interventional Study
Rheumatoid Arthritis
No Placebo Group
Every participant receives an active treatment — no one gets a placebo.
At a Glance
- Age
- 18 – 70
- Sex
- Any
- Trial phase
- Phase 1
- Study type
- Interventional
- Purpose
- Treatment
- Participants needed
- 48 (estimated)
- Sponsor
- Sonoma Biotherapeutics, Inc. · Industry
Who this trial is looking for
This trial is looking for adults with moderate to severe rheumatoid arthritis who have not responded well to other treatments. Participants will receive a single dose of SBT777101 and will be monitored for safety and effects.
Are You a Good Fit for This Trial?
You may be able to join if
- I have moderate to severe rheumatoid arthritis.
- I have a swollen joint count of 4 or more.
- I have not responded to at least two other rheumatoid arthritis treatments.
- I have been stable on my rheumatoid arthritis medications for at least 30 days.
- I can use effective birth control.
You may not be able to join if
- I have had major surgery in the last 12 weeks.
- I have uncontrolled heart, lung, kidney, liver, endocrine, or gut issues.
- I currently have an active infection or recurrent infections.
- I have active or untreated latent tuberculosis.
- I have a history of immune system issues.
- I have rheumatoid arthritis without any other inflammatory joint disease.
Summarized in plain language from this trial's official eligibility criteria. The full criteria are further down this page — only the research team can confirm whether you qualify.
Think this trial could be right for you?
Answer three quick questions written from this study's own rules to see if you may qualify. No account needed to find out.
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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 …
Trial Locations
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Eligibility Criteria
Inclusion Criteria:
* 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 respo…
Contacts