Study of Single Doses of SBT777101 in Subjects With Rheumatoid Arthritis
Part of paid clinical trials in Scottsdale, Arizona.
- Sponsor
- Sonoma Biotherapeutics, Inc.
- Study ID
- NCT06201416
- Phase
- PHASE1
- Status
- Recruiting
Conditions
Eligibility Criteria
- Sex
- ALL
- Age
- 18 Years - 70 Years
- Healthy Volunteers
- Not accepted
Interventions
- SBT777101 — BIOLOGICALExperimental treatment
Study Details
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.
Key Dates
- Start date
- Mar 6, 2024
- Status verified
- Apr 2026
- Primary completion
- Nov 30, 2026
- Completion
- Nov 30, 2026
Study Design
- Enrollment
- 24 participants (estimated)
- Allocation
- NON_RANDOMIZED
- Intervention model
- SEQUENTIAL
- Primary purpose
- TREATMENT
Arms
- Experimental: SBT777101 Dose 1Low dose SBT777101
- Experimental: SBT777101 Dose 2Mid dose SBT777101
- Experimental: SBT777101 Dose 3High dose SBT777101
Primary Outcome Measure
Incidence, nature, and severity of adverse events [Safety and Tolerability] [ Time Frame: Day of treatment to end of follow-up period (48 weeks) ]
Central Contacts
- Sabrina Fox-Bosetti, MPH415-992-6245
- Jason Do415-992-6245
Locations (8)
| Facility | City | State | ZIP | Site coordinators |
|---|---|---|---|---|
| Mayo Clinic | Scottsdale | Arizona | 85259 | |
| UCSF Medical Center | San Francisco | California | 94143 | |
| Stanford Medical Center | Stanford | California | 94305 | Uma Vilas Ayachit 925-860-8966 |
| University of Colorado | Aurora | Colorado | 80045 | Larry Moreland, MD (PRINCIPAL_INVESTIGATOR) |
| Northwestern University | Chicago | Illinois | 60611 | |
| Brigham and Women's Hospital | Boston | Massachusetts | 02115 | |
| Massachusetts General Hospital | Boston | Massachusetts | 02114 | |
| Tufts University | Boston | Massachusetts | 02111 |
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