3 results
The primary objective of the study is to evaluate the safety and tolerability of the Occlutech® AFR device by assessing the incidence of SADEs in the 3 months following implantation. Secondary objectives are related to safety and efficacy:• To…
Primary objective1. To test the safety of cold plasma treatment: SAE in * 10% of participants, no pain (VAT * 2) and no local skin reaction: redness, blister formation, pain or itching. Secondary objectives:The effect of cold plasma treatment on : 1…
This study aims to determine the safety, pharmacokinetics (PK) and recommended Phase 3 dose (RP3D) of RYZ101 in Part 1, and the safety, efficacy, and PK of RYZ101 compared with investigator-selected standard of care (SoC) therapy in Part 2 in…