A First-in-human Study of KT502 Administered Subcutaneously to Adult Participants With Rheumatoid… (NCT07564154) | Clinical Trial Compass
Not Yet RecruitingPhase 1
A First-in-human Study of KT502 Administered Subcutaneously to Adult Participants With Rheumatoid Arthritis (RA)
Australia, New Zealand27 participantsStarted 2026-07
Plain-language summary
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.
Who can participate
Age range18 Years – 75 Years
SexALL
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Inclusion criteria
✓. 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 criteria
✕. 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
What they're measuring
1
Incidence of Adverse Events
Timeframe: From Baseline Up to 12 weeks
2
Incidence of Cytokine-release Syndrome (CRS)
Timeframe: From Baseline Up to 12 Weeks
3
Changes in Pulse Rate from Baseline
Timeframe: From Baseline Up to 12 Weeks
4
Changes in Respiratory Rate from Baseline
Timeframe: From Baseline to 12 Weeks
5
Changes in Blood Pressure from Baseline
Timeframe: Baseline to 12 Weeks
6
Changes in Temperature from Baseline
Timeframe: Baseline to 12 Weeks
7
Changes in Hematology Clinical Laboratory Results from Baseline
Timeframe: From Baseline Up to 12 Weeks
8
Changes in Chemistry Clinical Laboratory Results from Baseline