Phase 1 Study of KT501 Injection to Assess Safety and Effects in Adults With Rheumatoid Arthritis

What this Trial Is About

Researchers are evaluating KT501, a monoclonal antibody, in an open-label, first-in-human Phase 1 study involving adults with Rheumatoid Arthritis RA. The study aims to investigate the safety, tolerability, and how the body processes and responds to a single subcutaneous dose of KT501. This study focuses on participants with moderately to severely active RA who have not responded adequately to previous treatments. Participants will be enrolled into up to 5 different dose groups, each receiving one single subcutaneous injection of KT501 on Day 1. The study includes dose escalation to assess different levels of the drug. After administration, participants are followed closely for 12 weeks to monitor effects, with additional follow-up up to 48 weeks for those who experience significant B cell depletion. During the study, participants will undergo various assessments including monitoring for adverse events, changes in vital signs such as pulse and blood pressure, and laboratory tests on blood and urine. Researchers will measure serum levels of KT501 at multiple time points up to Day 85, track immune responses such as B cell counts, and assess inflammatory markers. The total participation duration may extend up to 48 weeks for some individuals to ensure safety and thorough evaluation.

A First-in-human Study of KT501 Administered Subcutaneously to Patients With Rheumatoid Arthritis (RA).