Aim | Measure |
---|---|
To evaluate the safety of oral GlcNAc administration at two different, incremental doses in subjects with MS | The frequency and severity of all Adverse Events, during all three phases of the study (pre-treatment, on-treatment, and post-treatment) |
To evaluate the effect of 2 different oral GlcNAc doses on plasma GlcNAc levels To evaluate the ability of two different doses of oral GlcNAc to increase N-glycan branching in T cells To evaluate oral GlcNAc effects on pro-inflammatory TH1 and TH17 responses |
GlcNAc serum concentration was assessed using Liquid Chromatography–Mass Spectrometry (LC–MS/MS). Serum from all study visits of one individual was analysed at the same time to assess for changes over time Flow cytometry using the plant lectin L-PHA to assess for in vivo changes in N-glycan branching in T and B cells during GlcNAc administration (as a percent change from baseline). To assess changes over time in a single individual, PBMCs were thawed from all relevant study visits of the same individual at the same time and directly compared Serum from individuals before, during and after oral GlcNAc therapy was assessed for changes in IFNγ (TH1), IL-17 and IL-6 (TH17) as well as IL-10 (non-TH1/TH17) using sandwich ELISA |