A Phase 1 Study to Evaluate the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics, and Activity of Single Ascending Doses of SBT777101 in Subjects With Rheumatoid Arthritis
Status: Recruiting
Location: See all (8) locations...
Intervention Type: Biological
Study Type: Interventional
Study Phase: Phase 1
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.
Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 70
Healthy Volunteers: f
View:
• 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
Locations
United States
Arizona
Mayo Clinic
RECRUITING
Scottsdale
California
UCSF Medical Center
RECRUITING
San Francisco
Stanford Medical Center
RECRUITING
Stanford
Colorado
University of Colorado
RECRUITING
Aurora
Illinois
Northwestern University
RECRUITING
Chicago
Massachusetts
Brigham and Women's Hospital
RECRUITING
Boston
Massachusetts General Hospital
RECRUITING
Boston
Tufts University
RECRUITING
Boston
Contact Information
Primary
Sabrina Fox-Bosetti, MPH
clinicaloperations@sonomabio.com
415-992-6245
Backup
Ari Bitton
clinicaloperations@sonomabio.com
415-992-6245
Time Frame
Start Date: 2024-03-06
Estimated Completion Date: 2026-03
Participants
Target number of participants: 24
Treatments
Experimental: SBT777101 Dose 1
Low dose SBT777101
Experimental: SBT777101 Dose 2
Mid dose SBT777101
Experimental: SBT777101 Dose 3
High dose SBT777101
Related Therapeutic Areas
Sponsors
Leads: Sonoma Biotherapeutics, Inc.