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NCT06201416 · ClinicalTrials.gov record · last posted 2026-06-30

Study of Single Doses of SBT777101 in Subjects With Rheumatoid Arthritis

Study acronym: Regulate-RA
StatusRecruiting
PhasePhase 1
Started2024-03-06
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from the ClinicalTrials.gov record
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.

Protocol amendment history 2 changes detected by DataLookout

2026-07-01
notable
Enrollment increased: 24 → 48 participants
2026-07-01
minor
Trial arms changed: 3 → 4
Trial Details
NCT Number NCT06201416
Lead Sponsor Sonoma Biotherapeutics, Inc.
Conditions Rheumatoid Arthritis
Enrollment 48 participants
Start Date 2024-03-06
Primary Completion 2026-11 (estimated)
Study Completion 2026-11 (estimated)
Updated on ClinicalTrials.gov 2026-06-30