Phase 1 Study of KT502 Injected Under the Skin in Adults With Rheumatoid Arthritis to Evaluate Safety and Dosage

What this Trial Is About

Researchers are conducting a Phase 1, open-label study to evaluate the safety, tolerability, pharmacokinetics, and pharmacodynamics of KT502, a monoclonal antibody targeting CD19 and CD3 to deplete B cells, in adults with Rheumatoid Arthritis RA. This trial focuses on adult participants aged 18 to 75 years who have moderately to severely active RA and inadequate treatment response, aiming to understand how KT502 behaves and is tolerated when given by subcutaneous injection. The study has two parts Part A involves single ascending doses of KT502 to find appropriate dosing levels, while Part B uses fractionated dosing with injections on Day 1 and Day 8 to escalate the dose. Participants receive subcutaneous injections of KT502 at assigned doses according to their group, with dosing schedules designed to assess safety and drug behavior. Participants will be monitored for up to 12 weeks after dosing for adverse events, vital signs, and laboratory changes including blood chemistry and hematology. Additional blood samples will be taken at various time points to measure drug concentrations, immune response, and inflammation markers. The study includes regular assessments to track safety, drug levels, and immune effects over approximately three months, with ongoing data collection on laboratory and clinical parameters.

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