Study of Single Doses of SBT777101 in Subjects With Rheumatoid Arthritis

NCT ID
NCT06201416
Registry status
Recruiting
Study type
Interventional
Phase
Phase 1
Sponsor
Sonoma Biotherapeutics, Inc.
Conditions
Rheumatoid Arthritis

Overview

ClinicalTrials.gov lists this study as Recruiting.

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

Enrollment: 48 participants (Estimated).

What is being studied

  • Biological: SBT777101

Who may be eligible

Ages
18 Years to 70 Years
Sex
All
Healthy volunteers accepted
No

ClinicalTrials.gov lists the following 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

Study locations

9 study locations are listed.

Recruiting site status is explicitly provided for 9 locations; 9 are listed as Recruiting.

Countries: United States

  • Arizona, United States: 1
  • California, United States: 2
  • Colorado, United States: 1
  • Illinois, United States: 1
  • Massachusetts, United States: 3
  • Oregon, United States: 1

Sample of listed locations

  • Mayo Clinic — Scottsdale, Arizona, 85259, United States — Recruiting
  • UCSF Medical Center — San Francisco, California, 94143, United States — Recruiting
  • Stanford Medical Center — Stanford, California, 94305, United States — Recruiting
  • University of Colorado — Aurora, Colorado, 80045, United States — Recruiting
  • Northwestern University — Chicago, Illinois, 60611, United States — Recruiting
  • Brigham and Women's Hospital — Boston, Massachusetts, 02115, United States — Recruiting
  • Massachusetts General Hospital — Boston, Massachusetts, 02114, United States — Recruiting
  • Tufts University — Boston, Massachusetts, 02111, United States — Recruiting
  • Oregon Health Sciences University — Portland, Oregon, 97239, United States — Recruiting

Study details

Start date
March 6, 2024
Primary completion date
November 1, 2026
Completion date
November 1, 2026
First posted
January 11, 2024

Source and update information

Source
ClinicalTrials.gov
NCT ID
NCT06201416
Registry last updated
June 30, 2026
QualifiedStudies registry data refreshed
October 2, 2026
QualifiedStudies record fetched
October 2, 2026

View NCT06201416 on ClinicalTrials.gov

Trial information can change. Confirm current study details with the study team or the registry.

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