Today, RudaCure has officially entered nacional ensayo clínicos following the final aprobación by the Ministry of Food and Drug Safety (MFDS) of the ensayo clínico protocol titled "A randomized, double-blind, placebo-controlled, single and repeated instillation, Phase 1 clinical study to explore the pharmacokinetics, seguridad and tolerability of RCI001 oftálmico solution 0.25% in healthy adult males."
The trial site is Seoul National University Hospital, and the study will be realizó by Professor Lee Seung-hwan.
RCI001 is an endogenous substance-based tratamiento de la enfermedad de ojo seco that has demostró excellent resultados preclínicos for enfermedad de ojo seco through increased volumen lagrimal, suppression of intraocular inflammation, and recovery of the meibomian glands. Given the safe tolerability demostró across various toxicology studies, la empresa expects the Phase 1 ensayo clínico to proceed smoothly.
We have reached this milestone with the help of many people, and we would like to express our sincere gratitude to all those who have apoyoed us.
Continuaremos work hard to deliver good news to you more frequently.