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

Recruiting now · Phase 1

Conditions studied: Rheumatoid Arthritis (RA)

In brief

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).

Key facts

Study ID: NCT07234773
Run by: Kali Therapeutics, Inc.
People needed: 24
Starts: 2026-03-06
Expected to finish: 2027-08-01
Last updated by the study team: 2026-03-10

Who can join

Age: 18 and older, up to 75. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

18 to 75 years old
Diagnosis of adult-onset RA for at least 6 months
Moderately to severely active RA
Inadequate treatment response as defined in the protocol
RF + or ACPA+
Stable use of traditional DMARDs is permitted
Willing and able to comply with all study assessments and adhere to the protocol schedule and restrictions.

You may not qualify if…

Functional class IV as defined by the ACR Classification of Functional Status in RA
Presence of any concomitant autoimmune disease other than RA
Active infection, history of serious recurrent or chronic infection
History of progressive multifocal leukoencephalopathy
Have a diagnosis or history of malignant disease within 5 years or breast cancer diagnosed within the previous 10 years.
History of or planned organ transplant and/or autologous or allogeneic hematopoietic stem cell transplantation
Receipt of live vaccine within 4 weeks
Major surgery (including joint surgery) within 8 weeks prior to screening or planned major surgery within 6 months after study
Women who are pregnant or breastfeeding
Significant or uncontrolled medical disease that would preclude participant participation

Where it is running

Kali Study Site — Bayswater, Australia (enrolling)

Full record on ClinicalTrials.gov

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