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Study of Single Doses of SBT777101 in Subjects With Rheumatoid Arthritis
Recruiting
I'm InterestedTrial ID: NCT06201416
Purpose
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.
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
Stanford Investigator(s)
Tamiko Robin Katsumoto MD, DipABLM
Clinical Associate Professor, Medicine - Immunology & Rheumatology
Eligibility
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
Intervention(s):
biological: SBT777101
Recruiting
I'm InterestedContact Information
Stanford University
School of Medicine
300 Pasteur Drive
Stanford,
CA
94305
Emma Stainton
650-736-3472