NCT07234773RecruitingPhase 1
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
Source: ClinicalTrials.gov · Last updated 10 Mar 2026
Brief summary (registry, in English)
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).
- Status (registry)
- Recruiting
- Phase (registry)
- Phase 1
- Study type
- Interventional
- Enrollment
- 24 (estimated)
- First submitted
- 13 Nov 2025
- Start date
- 6 Mar 2026
- Primary completion date
- Feb 2027
- Lead sponsor
- Kali Therapeutics, Inc.
- Diseases
- Rheumatoid arthritis
- NCT number
- NCT07234773
What you commit to
- Study type: Interventional · Phase 1
- Planned participants: 24
- From 6 Mar 2026 to the primary completion date, Feb 2027
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- 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
Other illness
- 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
Other
- Functional class IV as defined by the ACR Classification of Functional Status in RA
- Women who are pregnant or breastfeeding
Who the study is looking for
- 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.
Age in the registry: 18 years to 75 years · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| - Coordinator of this site? Confirm its status | Bayswater | Australia | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.