Evaluation of immune status
inflammation
INFLAMMATION, PCT
In the phase I study in healthy subjects, pre-treatment immune status was evaluated at the cellular level (ALC, ANC, NLR, monocyte and platelet counts) by measurement of soluble markers of inflammation (serum CRP and albumin), and Ig levels (IgM, IgA, and IgG).In the phase II CIGMA trial, ALC, ANC, NLR, monocyte and platelet counts and serum CRP, PCT, albumin, IgM, IgA, and IgG were assessed pre-initiation of trimodulin (baseline). The course of these biomarkers was assessed during and shortly after treatment with trimodulin or placebo was concluded (up to Day 7).