Tests KT501 injection in adults with rheumatoid arthritis
Tests KT501, given under the skin, in adults with rheumatoid arthritis.
Plain-language title generated from the registry record
Registry title: A First-in-human Study of KT501 Administered Subcutaneously to Patients With Rheumatoid Arthritis (RA).
Key facts
- Where
- Bayswater, AustraliaSee the site
- Phase
- Phase 1
Could this be for you?
Answer for yourself. This is not a decision: only the study team can say whether you can take part.
- Are you between 18 and 75 years old?
Source: NCT07234773, who can take part
Where in Australia
- BayswaterBayswater, AustraliaTaking people
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- Kali Therapeutics, Inc.
- Trial code
- NCT07234773
- Record updated
- 10 March 2026
- Original description
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).Read full original descriptionShow less
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
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).
Inclusion: 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.
Exclusion: Presence of any concomitant autoimmune disease other than RA; 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; 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; Significant or uncontrolled medical disease that would preclude participant participation; Functional class IV as defined by the ACR Classification of Functional Status in RA; Women who are pregnant or breastfeeding.