RightFit
RecruitingPhase 1

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

Who can join

As published by the study on ClinicalTrials.gov. "Not stated" means the study hasn't said — ask the study team.

Age
18 Years to 70 Years
Sex
All sexes
Healthy volunteers
Not accepted
Compensation
Not stated

Other requirements are listed under Eligibility below. Only the study team can confirm whether you can join.

What to expect

No one can promise a trial will help you personally — that is what the research is trying to find out.

What participation involves

  • Procedures mentioned: Infusions

Only what the study's summary and detailed description on ClinicalTrials.gov say. Time periods may describe the whole study or a part of it — ask the study team what applies to you.

Show the study's own words
  • "In the split-dose cohort, participants may receive two intravenous infusions of SBT777101 derived from a single manufacturing process, administered approximately 6 weeks apart."
Compensation
Not stated
  • Study-related exams and procedures are typically provided at no cost. This is how many trials work in general — confirm the details for this study with the study team.
  • Participants are monitored closely by the research team throughout the study.
  • Some participants may receive access to an investigational treatment, which is still being studied.
  • Your participation helps researchers learn whether this approach could help future patients.

About this study

In plain language

This study tests the safety and effects of SBT777101 in people with moderate-to-severe rheumatoid arthritis (RA), a disease that causes swollen, painful joints. This is the first study of this treatment in humans, and higher doses will be tested only after lower doses are shown to be safe. Most participants will get one dose, but some may get the dose split into two treatments through a vein about 6 weeks apart.

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. Following completion of the initial single ascending dose cohorts, the study may evaluate alternative administration regimens of SBT777101, including split-dose administration. In the split-dose cohort, participants may receive two intravenous infusions of SBT777101 derived from a single manufacturing process, administered approximately 6 weeks apart. The study will continue to evaluate safety, tolerability, pharmacokinetics, pharmacodynamics, and preliminary clinical activity.

Compensation is read from the study's own description and may be missing — always confirm with the study team.

Eligibility

Who can join

  • Have a body mass index (BMI), a measure based on height and weight, below 35.
  • Have moderate-to-severe, active RA that started in adulthood.
  • Have tried at least 2 biologic or targeted RA medicines without success.
  • Have at least 4 swollen joints.
  • Have signs of swelling in the joint lining on an exam or ultrasound scan.
  • Have had poor results or could not tolerate available RA treatments.
  • Have taken the same doses of RA medicines for at least 30 days.
  • Use highly effective birth control.

Who can't join

  • Had major surgery within 12 weeks before screening, or plan to have it within 12 months after treatment.
  • Have an uncontrolled disease of the heart, lungs, kidneys, liver, hormone system, or digestive system.
  • Have an active infection or infections that keep coming back.
  • Have active tuberculosis (TB), or untreated TB that is inactive in the body.
  • Have a condition that weakens the immune system.
  • Have or have had a joint disease that causes inflammation other than RA.

Simplified for readability. The official criteria below are what the study team uses.

Official 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 sites (9)

AZ

CA

CO

IL

MA

OR