RecruitingPhase 1NCT07234773

A First-in-human Study of KT501 Administered Subcutaneously to Patients With Rheumatoid Arthritis (RA).

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


Sponsor

Kali Therapeutics, Inc.

Enrollment

24 participants

Start Date

Mar 6, 2026

Study Type

INTERVENTIONAL

Conditions

Summary

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).


Eligibility

Min Age: 18 YearsMax Age: 75 Years

Plain Language Summary

Simplified for easier understanding

This is a first-in-human study testing the safety of a new injectable drug called KT501 in people with moderate to severe rheumatoid arthritis (RA) — a condition where the immune system attacks the joints, causing pain and swelling. **You may be eligible if...** - You are between 18 and 75 years old - You have had a diagnosis of adult-onset rheumatoid arthritis for at least 6 months - Your RA is moderately to severely active - Previous RA treatments have not worked well enough for you - You test positive for certain RA-related antibodies (RF or ACPA) **You may NOT be eligible if...** - You have very severe functional disability from RA - You have another autoimmune disease in addition to RA - You have an active infection or history of serious recurrent infections - You have had cancer in the past 5 years (or breast cancer in the past 10 years) Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGKT501

KT501 is a monoclonal antibody that depletes B cells including plasma cells by targeting CD19, BCMA and CD3.


Locations(1)

Kali Study Site

Bayswater, Australia

View Full Details on ClinicalTrials.gov

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NCT07234773


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