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
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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