4 results
The objective of this pivotal study is to assess the PK and PD as well as safety and tolerability of RP103 compared to Cystagon® in patients with nephropathic cystinosis. Results of this Phase 3 study will be used to support the registration…
- To assess the pharmacokinetic profile of cysteamine base after single dose administration of the new sustained-release cysteamine bitartrate (PO-001) to healthy volunteers, in comparison with Cystagon® and Procysbi®.- To collect safety/…
The primary objective will be to investigate if a two-year course of TPTD followed by antiresorptive treatment with a single infusion of ZA in adults with OI reduces the proportion of patients who experience a fracture as compared with standard care…
Phase 1• To establish the RP2D regimen by evaluation of the safety and tolerability of intravenous (IV) administration of Lutetium (177Lu) rhPSMA-10.1 injection in subjects with mCRPC.Phase 2• To evaluate the efficacy of Lutetium (177Lu) rhPSMA-10.1…