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Recruiting Phase 1 Interventional

Study of Single Doses of SBT777101 in Subjects With Rheumatoid Arthritis

ClinicalTrials.gov ID: NCT06201416

Public ClinicalTrials.gov record NCT06201416. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.

ClinicalTrials.gov public records Last synced Sep 16, 2026, 5:50 PM EDT

Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.

Official title

A Phase 1 Study to Evaluate the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics, and Activity of Single Ascending Doses of SBT777101 in Subjects With Rheumatoid Arthritis

Brief summary

Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.

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.

Study identification

NCT ID
NCT06201416
Recruitment status
Recruiting
Study type
Interventional
Phase
Phase 1
Lead sponsor
Sonoma Biotherapeutics, Inc.
Industry
Enrollment
48 participants

Conditions and interventions

Interventions

Biological

Eligibility (public fields only)

Age range
18 Years to 70 Years
Sex
All
Healthy volunteers
Healthy volunteers not accepted

This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.

Study timeline

Start date
Mar 5, 2024
Primary completion
Oct 31, 2026
Completion
Oct 31, 2026
Last update posted
Jun 29, 2026

2024 – 2026

United States locations

U.S. sites
9
U.S. states
6
U.S. cities
7
Facility City State ZIP Site status
Mayo Clinic Scottsdale Arizona 85259 Recruiting
UCSF Medical Center San Francisco California 94143 Recruiting
Stanford Medical Center Stanford California 94305 Recruiting
University of Colorado Aurora Colorado 80045 Recruiting
Northwestern University Chicago Illinois 60611 Recruiting
Tufts University Boston Massachusetts 02111 Recruiting
Massachusetts General Hospital Boston Massachusetts 02114 Recruiting
Brigham and Women's Hospital Boston Massachusetts 02115 Recruiting
Oregon Health Sciences University Portland Oregon 97239 Recruiting

Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.

About this trial record page

What this page shows
Public field values for ClinicalTrials.gov record NCT06201416, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
What this page does not do
No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
Where the data comes from
Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
Last refresh
Last update posted Jun 29, 2026 · Synced Sep 16, 2026

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Open the official record

The complete protocol, eligibility criteria, and contact information for NCT06201416 live on ClinicalTrials.gov.

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