RECRUITING

Study of Single Doses of SBT777101 in Subjects With Rheumatoid Arthritis

Description

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.

Conditions

Rheumatoid Arthritis
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Related Conditions:

Rheumatoid Arthritis

Study Overview

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Study Details

Study overview

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.

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

Study of Single Doses of SBT777101 in Subjects With Rheumatoid Arthritis

Condition
Rheumatoid Arthritis
Intervention / Treatment

-

Contacts and Locations

Scottsdale

Mayo Clinic, Scottsdale, Arizona, United States, 85259

San Francisco

UCSF Medical Center, San Francisco, California, United States, 94143

Stanford

Stanford Medical Center, Stanford, California, United States, 94305

Aurora

University of Colorado, Aurora, Colorado, United States, 80045

Chicago

Northwestern University, Chicago, Illinois, United States, 60611

Boston

Tufts University, Boston, Massachusetts, United States, 02111

Boston

Massachusetts General Hospital, Boston, Massachusetts, United States, 02114

Boston

Brigham and Women's Hospital, Boston, Massachusetts, United States, 02115

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

For general information about clinical research, read Learn About Studies.

Eligibility Criteria

  • * Body mass index (BMI) \<35 kg/m\^2, inclusive
  • * Adult-onset, moderate-to-severe rheumatoid arthritis (RA)
  • * Moderate-to-severe active disease
  • * 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
  • * 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

Ages Eligible for Study

18 Years to 70 Years

Sexes Eligible for Study

ALL

Accepts Healthy Volunteers

No

Collaborators and Investigators

Sonoma Biotherapeutics, Inc.,

Joseph Arron, MD, STUDY_DIRECTOR, Sonoma Biotherapeutics, Inc.

Study Record Dates

2026-03