Phase 1 Study Evaluating Safety and Effects of GSK4527363 in Healthy Adults, Patients with Systemic Lupus Erythematosus, Healthy Japanese and Chinese Adults, and Patients with Connective Tissue Disease-Related Lung Disease

What this Trial Is About

Researchers are studying GSK4527363 in a phase 1 clinical trial to evaluate its safety, tolerability, pharmacokinetics, pharmacodynamics, and immunogenicity. This study includes healthy participants, people with systemic lupus erythematosus SLE, healthy individuals of Chinese and Japanese ancestry, and participants with interstitial lung disease linked to connective tissue disease CTD-ILD. The trial includes multiple groups to understand how the drug behaves across these populations. Participants receive GSK4527363, placebo matching GSK4527363, or belimumab, depending on their group. The study is divided into four parts Part A involves healthy volunteers, Part B includes participants with active SLE, Part C enrolls healthy Chinese and Japanese participants, and Part D involves those with CTD-ILD. Treatments and assessments occur over different durations, up to 52 weeks for healthy participants and up to 68 weeks for those with SLE or CTD-ILD. During the study, participants undergo medical evaluations including physical exams, lab tests, vital signs monitoring, and 12-lead ECGs. Researchers track adverse events, immune responses, drug levels in the blood, and changes in cytokine levels. Safety and tolerability are monitored closely through these measures. The total participation time varies by group, extending up to 68 weeks for some. This comprehensive monitoring helps assess the drugs effects and safety in diverse participants.

A Study of GSK4527363 in Healthy Participants, Systemic Lupus Erythematosus (SLE) Participants, Healthy Chinese, and Japanese Participants and CTD-ILD Participants