Actively Recruiting
A Phase 1a, Open-Label, First-in-Human Study to Investigate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of KT501 by a Single Subcutaneous Administration in Participants With Rheumatoid Arthritis
Led by Kali Therapeutics, Inc. · Updated on 2026-03-10
24
Participants Needed
1
Research Sites
25 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating KT501, a monoclonal antibody, in an open-label, first-in-human Phase 1 study involving adults with Rheumatoid Arthritis (RA). The study aims to investigate the safety, tolerability, and how the body processes and responds to a single subcutaneous dose of KT501. This study focuses on participants with moderately to severely active RA who have not responded adequately to previous treatments. Participants will be enrolled into up to 5 different dose groups, each receiving one single subcutaneous injection of KT501 on Day 1. The study includes dose escalation to assess different levels of the drug. After administration, participants are followed closely for 12 weeks to monitor effects, with additional follow-up up to 48 weeks for those who experience significant B cell depletion. During the study, participants will undergo various assessments including monitoring for adverse events, changes in vital signs such as pulse and blood pressure, and laboratory tests on blood and urine. Researchers will measure serum levels of KT501 at multiple time points up to Day 85, track immune responses such as B cell counts, and assess inflammatory markers. The total participation duration may extend up to 48 weeks for some individuals to ensure safety and thorough evaluation.
CONDITIONS
Brief 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...
- Age between 18 and 75 years
- Diagnosis of adult-onset Rheumatoid Arthritis for at least 6 months
- Moderately to severely active Rheumatoid Arthritis
- Inadequate treatment response as defined in the protocol
- Positive for rheumatoid factor or anti-citrullinated protein antibody
- Stable use of traditional disease-modifying antirheumatic drugs (DMARDs) permitted
- Willing and able to comply with all study assessments and protocol schedule
You will not qualify if you...
- Functional class IV Rheumatoid Arthritis as defined by ACR classification
- Any other autoimmune disease besides Rheumatoid Arthritis
- Active infection or history of serious, recurrent, or chronic infections
- History of progressive multifocal leukoencephalopathy
- Diagnosis or history of malignant disease within 5 years, or breast cancer within 10 years
- History or planned organ transplant or stem cell transplantation
- Receipt of live vaccine within 4 weeks prior to screening
- Major surgery within 8 weeks prior or planned within 6 months after screening
- Women who are pregnant or breastfeeding
- Significant or uncontrolled medical conditions preventing participation
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Day 1
Participants receive a single subcutaneous dose of KT501 to assess safety, tolerability, and pharmacokinetics.
1 treatment visit (in-person)
Duration - Up to 48 weeks
Participants are monitored for safety and pharmacodynamic effects up to 12 weeks after treatment. Additional B cell follow-up is required up to Week 48 for some participants depending on their B cell levels.
Multiple visits up to Week 12; additional visits up to Week 48 for some participants
Trial Site Locations
Total: 1 location
1
Kali Study Site
Bayswater, Australia
Actively Recruiting
Research Team
T
Trial Information
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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