Today, RudaCure has officially entered domestic 临床试验 following the final approval by the 食品医药品安全处 (MFDS) of the 临床试验 protocol titled "A randomized, double-blind, placebo-controlled, single and repeated 滴眼, Phase 1 clinical study to explore the 药代动力学, safety and tolerability of RCI001 眼科 solution 0.25% in healthy adult males."
The trial site is 首尔大学医院, and the study will be conducted by Professor Lee Seung-hwan.
RCI001 is an endogenous substance-based 干眼症治疗药 that has demonstrated excellent 临床前结果 for 干眼症 through increased 泪液量, suppression of intra眼部 炎症, and recovery of the meibomian glands. Given the safe tolerability demonstrated across various toxicology studies, the company expects the Phase 1 临床试验 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 supported us.
We will continue to work hard to deliver good news to you more frequently.