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Recruiting

A First-in-human Study of KT502 in Adult Participants With Rheumatoid Arthritis (RA)

NCT07564154 · Kali Therapeutics, Inc.
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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
About this study
This is a Phase 1, open-label, first-in-human study to investigate the safety, tolerability, pharmacokinetics and pharmacodynamics of KT502 administered subcutaneously to participants with Rheumatoid Arthritis (RA). The study will have 2 parts: Part A is a single ascending dose finding (SAD) and Part B is dose escalation by fractionated dosing.
Eligibility 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
Study design
Enrollment target: 27 participants
Allocation: non_randomized
Masking: none
Age groups: adult, older_adult
Timeline
Starts: 2026-07-13
Estimated completion: 2028-07
Last updated: 2026-08-11
Interventions
Drug: KT502
Primary outcomes
  • Incidence of Adverse Events (From Baseline Up to 12 weeks)
  • Incidence of Cytokine-release Syndrome (CRS) (From Baseline Up to 12 Weeks)
  • Changes in Pulse Rate from Baseline (From Baseline Up to 12 Weeks)
Sponsor
Kali Therapeutics, Inc. · industry
Contacts & investigators
ContactTrial Information · contact · clinical@kalitherapeutics.com · 1-858-888-3080
All locations (2)
Kali Therapeutics Trial SiteRecruiting
Bayswater, Victoria, Australia
Kali Therapeutics Trial SiteRecruiting
Auckland, NZ, New Zealand