Safety, Tolerability and Efficacy of GcMAF in Patients With Chronic Inflammatory Diseases

GcMAF is an immunomodulatory protein derived from vitamin D-binding protein via enzymatic deglycosylation. In this study, GcMAF will be administered (e.g., subcutaneously) once or twice-weekly for 12-16 weeks, followed by a 4-8-week observation period. The primary objectives include assessing clinical efficacy in chronic inflammatory conditions and confirming safety. GcMAF activates macrophages and dendritic cells, modulates M1/M2 profiles, and may reduce inflammatory markers such as CRP and ESR.

Participants in the placebo arm will receive a visually matching injection of normal saline (placebo) on the same schedule as the GcMAF arm (e.g., once or twice-weekly for 12-16 weeks). This allows for double-blind comparison of safety and efficacy endpoints. The placebo is designed to be identical in appearance and administration route to maintain blinding for investigators and participants.