3 results
2.1.1 Primary Objective1.Evaluate the LDL-C-lowering effects of ERN/LRPT/SIM 2 g/20 mg compared to ERN/LRPT 2 g coadministered with simvastatin 20 mg.Hypothesis: ERN/LRPT/SIM 2 g/20 mg is equivalent to ERN/LRPT 2 g coadministered with simvastatin 20…
To evaluate whether a faecal calprotectin guided strategy of anti-TNF dosing interval lengthening is non-inferior in maintaining remission in patients with IBD compared with an unchanged dosing interval.
Part A (Healthy volunteers)Primary:• To assess safety and tolerability of multiple doses of NX210cSecondary• To evaluate the pharmacokinetic (PK) profile of NX210c in plasma after multiple doses. • To evaluate the exposure of NX210c in cerebrospinal…