NCT07564154RecruitingPhase 1
A First-in-human Study of KT502 in Adult Participants With Rheumatoid Arthritis (RA)
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
Source: ClinicalTrials.gov · Last updated 11 Aug 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 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.
- Status (registry)
- Recruiting
- Phase (registry)
- Phase 1
- Study type
- Interventional
- Enrollment
- 27 (estimated)
- First submitted
- 27 Apr 2026
- Start date
- 13 Jul 2026
- Primary completion date
- 31 Dec 2027
- Lead sponsor
- Kali Therapeutics, Inc.
- Diseases
- Rheumatoid arthritis
- NCT number
- NCT07564154
What you commit to
- Study type: Interventional · Phase 1
- Planned participants: 27
- From 13 Jul 2026 to the primary completion date, 31 Dec 2027
- 2 sites in 2 countries
- 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.
Criteria the registry did not label
- 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:
- 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
Age in the registry: 18 years to 75 years · Sex: All · Does not accept healthy volunteers
Sites (2)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Kali Therapeutics Trial Site Coordinator of this site? Confirm its status | Bayswater | Australia | Recruiting |
| Kali Therapeutics Trial Site Coordinator of this site? Confirm its status | Auckland | New Zealand | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.