RECRUITINGPhase 1INTERVENTIONAL
Study of Single Doses of SBT777101 in Subjects With Rheumatoid Arthritis
A Phase 1 Study to Evaluate the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics, and Activity of Single Ascending Doses of SBT777101 in Subjects With Rheumatoid Arthritis
About This Trial
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.
Who May Be Eligible (Plain English)
Who May Qualify:
- 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
Who Should NOT Join This Trial:
- 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 weakened immune system
- History of or current inflammatory joint disease other than RA
Always talk to your doctor about whether this trial is right for you.
Original Eligibility Criteria
View original clinical language
Inclusion 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
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
Treatments Being Tested
BIOLOGICAL
SBT777101
Experimental treatment
Locations (8)
Mayo Clinic
Scottsdale, Arizona, United States
UCSF Medical Center
San Francisco, California, United States
Stanford Medical Center
Stanford, California, United States
University of Colorado
Aurora, Colorado, United States
Northwestern University
Chicago, Illinois, United States
Tufts University
Boston, Massachusetts, United States
Massachusetts General Hospital
Boston, Massachusetts, United States
Brigham and Women's Hospital
Boston, Massachusetts, United States