3 results
To determine if adjusting endotracheal tube cuff pressure after placement of a retractor during anterior cervical spine surgery prevents postoperative dysphagia. Furthermore laryngo-tracheal complaints (hoarseness and sore throat) will be scored.
Dose escalation phase:Primary• Determine the RP2D and if reached, the MTD of GEN3014• Evaluate the safety and tolerability of GEN3014 Secondary:• Characterize the PK properties of GEN3014• Characterize the pharmacodynamic properties of GEN3014•…
Primary:To evaluate the efficacy of 3 doses of RhuDex vs placebo for the treatment of PBC in patients with an inadequate response to UDCA.Secondary:• To identify efficacious RhuDex dose(s) for the treatment of PBC for further evaluation in phase III…