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Monoclonal Antibodies

SBT777101 Dose 3 for Rheumatoid Arthritis

Phase 1

Recruiting

Research Sponsored by Sonoma Biotherapeutics, Inc.

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Moderate-to-severe active disease

Prior inadequate response to or unable to tolerate available RA therapies

Timeline

Screening 3 weeks

Treatment Varies

Follow Up day of treatment to end of follow-up period (48 weeks)

Awards & highlights

Study Summary

This trial is testing a new treatment called SBT777101 for people with rheumatoid arthritis. The study will look at whether it is safe and how it affects the participants. The treatment will be

Who is the study for?

This trial is for adults with moderate-to-severe rheumatoid arthritis who haven't responded well to existing treatments. Participants must have a BMI under 35, at least one joint suitable for biopsy, and evidence of inflammation. They should be on stable RA medication doses for 30 days and use effective contraception. Excluded are those with recent major surgery, uncontrolled diseases in various organs, frequent infections or active tuberculosis, and other inflammatory joint diseases.Check my eligibility

What is being tested?

The study tests SBT777101's safety and effects as a single dose in humans with rheumatoid arthritis. It starts at low doses which increase once earlier levels are proven safe. This is the first time this treatment is being tested in people.See study design

What are the potential side effects?

Since this is the first human trial of SBT777101, specific side effects aren't listed yet but may include typical drug reactions such as injection site discomfort, allergic reactions, or symptoms related to immune system changes.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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My condition is currently moderate to severe.

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I have not responded well to or couldn't tolerate existing RA treatments.

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I have moderate-to-severe rheumatoid arthritis that started in adulthood.

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I have a joint suitable for a biopsy.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ day of treatment to end of follow-up period (48 weeks)

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~day of treatment to end of follow-up period (48 weeks)

This trial's timeline: 3 weeks for screening, Varies for treatment, and day of treatment to end of follow-up period (48 weeks) for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Incidence and nature of dose-limiting toxicities (DLTs)

Incidence, nature, and severity of adverse events [Safety and Tolerability]

Trial Design

3Treatment groups

Experimental Treatment

Group I: SBT777101 Dose 3Experimental Treatment1 Intervention

High dose SBT777101

Group II: SBT777101 Dose 2Experimental Treatment1 Intervention

Mid dose SBT777101

Group III: SBT777101 Dose 1Experimental Treatment1 Intervention

Low dose SBT777101

0 / 4Eligibility criteria met

Find a Location

Who is running the clinical trial?

Sonoma Biotherapeutics, Inc.Lead Sponsor

2 Previous Clinical Trials

64 Total Patients Enrolled

Mark Eisner, MDStudy DirectorSonoma Biotherapeutics, Inc.

1 Previous Clinical Trials

24 Total Patients Enrolled

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

What is the total number of participants involved in this clinical research study?

"Indeed, the information provided on clinicaltrials.gov affirms that this particular clinical trial is currently actively seeking eligible candidates. The trial was originally posted on January 1st, 2024 and underwent its most recent revision on the same date. In order to complete the study successfully, a total of 24 participants will be recruited from three distinct sites."

Answered by AI

Is it possible for me to participate in this research investigation?

"In order to be eligible for enrollment in this clinical trial, individuals must have a confirmed diagnosis of rheumatoid arthritis and fall within the age range of 18 to 70 years. The study aims to recruit approximately 24 participants."

Answered by AI

Are there any vacancies available for patients to participate in this trial?

"Indeed, as per clinicaltrials.gov, this investigation is currently in search of eligible participants. The trial was initially listed on January 1st, 2024 and recently updated on the same date."

Answered by AI

What are the potential risks associated with administering Dose 1 of SBT777101 to individuals?

"Based on the classification of this trial as Phase 1, indicating limited supporting data for safety and efficacy, our team at Power rates the safety of SBT777101 Dose 1 as a score of 1."

Answered by AI

Are individuals above the age of 25 eligible to participate in this medical study?

"To be considered eligible for this clinical trial, individuals must fall within the age range of 18 to 70. It is worth noting that there are a total of 53 trials available for patients under 18 and an additional 313 trials catering specifically to those over the age of 65."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Study of Single Doses of SBT777101 in Subjects With Rheumatoid Arthritis

2024. "Study of Single Doses of SBT777101 in Subjects With Rheumatoid Arthritis". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT06201416.

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