KT502 first-in-human test in adults with rheumatoid arthritis
Official title: A Phase 1, Open-Label, First-in-Human Study to Investigate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of KT502 by Subcutaneous Administration in Adult Participants With Rheumatoid Arthritis
Run by Kali Therapeutics, Inc. · NCT07564154 · Data updated 2026-11-12
A first-in-human, Phase 1 study will test KT502 in adults with moderately to severely active rheumatoid arthritis to see if it is safe and tolerable.
Quick facts
| Phase | Phase 1 |
|---|---|
| Study type | Interventional |
| Ages | 18 Years to 75 Years |
| Sex | All |
| Enrollment | 27 (estimated) |
| Sponsor | Kali Therapeutics, Inc. Industry-sponsored |
| Locations | 2 sites (Bayswater, Victoria and 1 other locations) |
| Status | Recruiting |
| Started | July 13, 2026 |
| Main results expected | December 2027 |
| Study ends | July 2028 |
| Registry record updated | August 11, 2026 |
| Trial ID | NCT07564154 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Adults 18 to 75 with moderately to severely active RA and inadequate response to traditional DMARDs.
✕Probably not a fit
Participants with significant comorbidities or those who do not experience tolerability or pharmacodynamic signals may not benefit.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This Phase 1, open-label trial will evaluate KT502 given subcutaneously in adults with rheumatoid arthritis. The study has two parts: Part A analyzes single ascending doses to identify tolerability and PK/PD, and Part B uses dose escalation with fractionated dosing to further characterize safety and pharmacodynamics. Primary goals are safety, tolerability, pharmacokinetics and pharmacodynamics, with inclusion criteria focused on adults with RA who have inadequate response to traditional DMARDs. Exclusion criteria include high disease activity with functional impairment, active infections, certain prior malignancies, and recent organ transplants or live vaccines. The study is conducted at Kali Therapeutics sites in Bayswater, Australia and Auckland, New Zealand.
Why it matters
Potential benefit: If KT502 proves safe and tolerable, it could pave the way for further development as a new option for RA patients.
How similar studies have gone: Similar first-in-human studies of targeted immune therapies in RA have shown safety signals and pharmacodynamic activity, supporting progression to later phases.
Who can join: the full rules
Show full inclusion / exclusion criteria
Inclusion: 1. 18 to 75 years old 2. Diagnosis of adult-onset RA for at least 6 months 3. Moderately to severely active RA 4. Inadequate treatment response as defined in the protocol 5. RF + or ACPA+ 6. Stable use of traditional DMARDs is permitted 7. Willing and able to comply with all study assessments and adhere to the protocol schedule and restrictions. Exclusion: 1. Functional class IV as defined by the ACR Classification of Functional Status in RA 2. Presence of any concomitant autoimmune disease other than RA 3. Active infection, history of serious recurrent or chronic infection 4. History of progressive multifocal leukoencephalopathy 5. Have a diagnosis or history of malignant disease within 5 years or breast cancer diagnosed within the previous 10 years. 6. History of or planned organ transplant and/or autologous or allogeneic hematopoietic stem cell transplantation 7. Receipt of live vaccine within 4 weeks 8. Major surgery (including joint surgery) within 8 weeks prior to screening or planned major surgery within 6 months after study 9. Women who are pregnant or breastfeeding 10. Significant or uncontrolled medical disease that would preclude participant participation
Where it's running
-
Kali Therapeutics Trial Site
Bayswater, Victoria, Australia Recruiting -
Kali Therapeutics Trial Site
Auckland, Nz, New Zealand Recruiting
Study contacts
- Study coordinator: Trial Information
- Email: clinical@kalitherapeutics.com
- Phone: 1-858-888-3080
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.