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.（纳斯达克股票代码：HUGE）（CSE: HUGE）（FRA: 0K9A）（“公司” 的 “FSD Pharma”）是一家生物制药公司，致力于为治疗具有挑战性的神经退行性、炎症和代谢性疾病建立创新资产和生物技术解决方案组合，今天宣布与佛罗里达州坦帕的应用科学与性能研究所（ASPI）签订协议 2024年4月24日将开展 “一项随机、双盲、安慰剂对照的交叉研究，以评估健康志愿者中unbuzd的安全性和有效性酒精中毒的诱发状态（METAL-2 试验）”。
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 是一种独特的膳食补充剂，含有天然成分、维生素和 GRAS（公认是安全的）成分，有可能增强认知能力，补充酒精代谢所需的辅助因子，并可能加速体内的酒精代谢。在 METAL-2 试验中，将对抗急性酒精中毒后果的能力与交叉设计中的安慰剂进行比较，试验中随机抽取了三十名健康志愿者。FSD Pharma将这项技术授权给Celly Nutrition Corp.，用于娱乐性销售 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.
“鉴于ASPI在健康和保健行业膳食补充剂临床试验方面的专业知识，我们很高兴能与ASPI敏捷而经验丰富的团队合作进行这项研究。FSD Pharma首席执行官兼创始人Zeeshan Saeed先生说：“这项试验标志着一个关键的里程碑，我们认为这对于使我们公司成为针对酒精中毒产品的领导者非常重要。