Actively Recruiting
A First-in-human Study of KT501 Administered Subcutaneously to Patients With Rheumatoid Arthritis (RA).
Led by Kali Therapeutics, Inc. · Updated on 2026-03-10
24
Participants Needed
1
Research Sites
73 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
This is a Phase 1, open-label, first-in-human study to investigate the safety, tolerability, pharmacokinetics and pharmacodynamics of KT501 administered subcutaneously to participants with Rheumatoid Arthritis (RA).
CONDITIONS
Official Title
A First-in-human Study of KT501 Administered Subcutaneously to Patients With Rheumatoid Arthritis (RA).
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Be between 18 and 75 years old
- Have adult-onset Rheumatoid Arthritis diagnosed for at least 6 months
- Have moderately to severely active Rheumatoid Arthritis
- Have had an inadequate response to previous treatments as defined in the study
- Be positive for Rheumatoid Factor (RF) or Anti-Citrullinated Protein Antibody (ACPA)
- Be on stable doses of traditional Disease-Modifying Anti-Rheumatic Drugs (DMARDs), if used
- Be willing and able to follow all study assessments and the study schedule
You will not qualify if you...
- Have Functional Class IV Rheumatoid Arthritis as defined by the American College of Rheumatology
- Have any other autoimmune disease besides Rheumatoid Arthritis
- Have an active infection or history of serious recurrent or chronic infections
- Have a history of progressive multifocal leukoencephalopathy
- Have had malignant disease within 5 years or breast cancer within the last 10 years
- Have a history of or planned organ transplant or hematopoietic stem cell transplantation
- Have received a live vaccine within 4 weeks before the study
- Have had major surgery within 8 weeks before screening or plan major surgery within 6 months after
- Be pregnant or breastfeeding
- Have significant or uncontrolled medical conditions that would prevent participation
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 1 location
1
Kali Study Site
Bayswater, Australia
Actively Recruiting
Research Team
T
Trial Information
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NON_RANDOMIZED
Model
SEQUENTIAL
Primary Purpose
TREATMENT
Number of Arms
5
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