FSD Pharma Signs Agreement With Applied Science And Performance Institute To Conduct A Clinical Trial In The U.S. To Assess The Safety And Efficacy Of 'Unbuzzd' In An Induced State Of Alcohol Intoxication
FSD Pharma Signs Agreement With Applied Science And Performance Institute To Conduct A Clinical Trial In The U.S. To Assess The Safety And Efficacy Of 'Unbuzzd' In An Induced State Of Alcohol Intoxication
FSD Pharma Inc. (NASDAQ:HUGE)(CSE:HUGE)(FRA:0K9A) ("FSD Pharma" of the "Company"), a biopharmaceutical company dedicated to building a portfolio of innovative assets and biotech solutions for the treatment of challenging neurodegenerative, inflammatory, and metabolic disorders, today announced that it entered into agreement with Applied Science and Performance Institute (ASPI) in Tampa, Florida, on April 24, 2024 to conduct "A Randomized, Double-Blind, Placebo-Controlled Crossover Study to Assess the Safety and Efficacy of unbuzzd in Healthy Volunteers in an Induced State of Alcohol Intoxication (METAL-2 TRIAL)".
FSD Pharma Inc.（納斯達克股票代碼：HUGE）（CSE: HUGE）（FRA: 0K9A）（“公司” 的 “FSD Pharma”）是一家生物製藥公司，致力於爲治療具有挑戰性的神經退行性、炎症和代謝性疾病建立創新資產和生物技術解決方案組合，今天宣佈與佛羅里達州坦帕的應用科學與性能研究所（ASPI）簽訂協議 2024年4月24日將開展 “一項隨機、雙盲、安慰劑對照的交叉研究，以評估健康志願者中unbuzd的安全性和有效性酒精中毒的誘發狀態（METAL-2 試驗）”。
unbuzzd is a unique dietary supplement with natural ingredients, vitamins and GRAS (Generally Recognized as Safe) ingredients that potentially enhances cognition, replenishes cofactors needed for alcohol metabolism, and may accelerate alcohol metabolism in the body. In the METAL-2 trial, the ability of unbuzzd to reverse the effects of acute alcohol intoxication will be compared to a placebo in a crossover design with thirty healthy volunteers randomized in the trial. FSD Pharma licensed this technology to Celly Nutrition Corp. for the recreational sale of unbuzzd.
unbuzzd 是一種獨特的膳食補充劑，含有天然成分、維生素和 GRAS（公認是安全的）成分，有可能增強認知能力，補充酒精代謝所需的輔助因子，並可能加速體內的酒精代謝。在 METAL-2 試驗中，將對抗急性酒精中毒後果的能力與交叉設計中的安慰劑進行比較，試驗中隨機抽取了三十名健康志願者。FSD Pharma將這項技術授權給Celly Nutrition Corp.，用於娛樂性銷售 unbuzzd。
"We are thrilled to be working with ASPI's agile and experienced team to conduct this study given their expertise in clinical trials with dietary supplements in the health and wellness industry. This trial marks a key milestone and we believe is important in establishing our company as a leader in products targeting alcohol intoxication" said Mr. Zeeshan Saeed, CEO and founder of FSD Pharma.
“鑑於ASPI在健康和保健行業膳食補充劑臨床試驗方面的專業知識，我們很高興能與ASPI敏捷而經驗豐富的團隊合作進行這項研究。FSD Pharma首席執行官兼創始人Zeeshan Saeed先生說：“這項試驗標誌着一個關鍵的里程碑，我們認爲這對於使我們公司成爲針對酒精中毒產品的領導者非常重要。