NCT06201416 Study of Single Doses of SBT777101 in Subjects With Rheumatoid Arthritis
| NCT ID | NCT06201416 |
| Status | Recruiting |
| Phase | Phase 1 |
| Sponsor | Sonoma Biotherapeutics, Inc. |
| Condition | Rheumatoid Arthritis |
| Study Type | INTERVENTIONAL |
| Enrollment | 48 participants |
| Start Date | 2024-03-06 |
| Primary Completion | 2026-11 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 1 is the earliest stage of human testing — safety and dosage are the primary focus. Visits are frequent and medical supervision is intensive. You will be among the first people to receive this treatment.
This trial targets 48 participants in total. It began in 2024-03-06 with a primary completion date of 2026-11.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
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
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 response to or unable to tolerate available RA therapies * Stable doses of RA medications for at least 30 days * Use of highly effective methods of contraception Exclusion Criteria: * 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 * Primary or secondary immunodeficiency * History of or current inflammatory joint disease other than RA
Contact & Investigator
Sarah Baxter, MD, PhD
STUDY DIRECTOR
Sonoma Biotherapeutics, Inc.
Frequently Asked Questions
Who can join the NCT06201416 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 70 Years, studying Rheumatoid Arthritis. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT06201416 trial and what does that mean for participants?
Phase 1 trials are the first stage of human testing. The primary goal is to assess safety and determine appropriate dosage levels. Participants are closely monitored. These trials typically involve a small number of volunteers.
Is NCT06201416 currently recruiting?
Yes, NCT06201416 is actively recruiting participants. Contact the research team at clinicaloperations@sonomabio.com for enrollment information.
Where is the NCT06201416 trial being conducted?
This trial is being conducted at Scottsdale, United States, San Francisco, United States, Stanford, United States, Aurora, United States and 5 additional locations.
Who is sponsoring the NCT06201416 clinical trial?
NCT06201416 is sponsored by Sonoma Biotherapeutics, Inc.. The principal investigator is Sarah Baxter, MD, PhD at Sonoma Biotherapeutics, Inc.. The trial plans to enroll 48 participants.
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