EXCLUSIVE: Adial Pharmaceuticals Starts Patient Dosing In Pharmacokinetics Study Of AD04 For Alcohol Use Disorder
EXCLUSIVE: Adial Pharmaceuticals Starts Patient Dosing In Pharmacokinetics Study Of AD04 For Alcohol Use Disorder
Wednesday, Adial Pharmaceuticals Inc. (NASDAQ:ADIL) announced that the first patient had been dosed in a pharmacokinetics study of AD04 for Alcohol Use Disorder in heavy drinking patients.
Adial pharmaceuticals公司（纳斯达克：ADIL）周三宣布，第一位接受AD04酒精使用障碍药物的药动学研究的患者已开始服药治疗。该研究旨在针对酗酒患者进行，预计耗时六个月，旨在产生数据，以帮助公司优化AD04的III期临床试验的研究设计要素。
The study is expected to take six months to complete and is intended to produce data that will help the company optimize the study design elements needed for the upcoming Phase 3 clinical trial of AD04.
这项研究预计将耗时六个月，旨在产生数据，以帮助公司优化AD04的III期临床试验的研究设计要素。
Completion of this study will also satisfy a requirement of the FDA guidance for the upcoming Phase 3 clinical trial of AD04.
本研究的完成还将满足FDA对AD04的III期临床试验的要求。
Related: EXCLUSIVE: Alcohol Disorder-Focused Adial Pharmaceuticals Secures US Patent.
相关文章:独家消息：专注于酒精障碍的Adial pharmaceuticals获得了美国专利。
"This relatively short and low-cost study is also a key element of our strategy to advance ongoing partnership discussions. The study will also provide data necessary to support an application for approval of AD04 under a 505(b)(2) regulatory pathway with FDA."
“这个相对较短、成本较低的研究也是我们推进正在进行的合作伙伴讨论的关键要素。该研究还将提供支持以申请在FDA的505(b)(2)监管路径下批准AD04所必需的数据。”
The pharmacokinetics study will involve two cohorts conducted consecutively and is expected to be completed in early Q4 2024.
药代动力学研究将依次进行两个队列，预计将在2024年第四季度初完成。
The single-center, relative bioavailability, open-label study will enroll up to 30 healthy adult volunteers and compare the pharmacokinetic profile of oral AD04 of 0.33 mg taken twice daily with or without food against a reference standard product.
单中心、相对生物利用度开放试验将招募多达30名健康成年志愿者，比较口服0.33毫克AD04和标准参比制剂在空腹或饮食状态下所产生的药代动力学特征。
This study will provide information on the pharmacokinetic properties of AD04. The company expects to report topline results in early Q4 2024.
该研究将提供AD04的药代特性信息。该公司预计将在2024年第四季度初发布顶线结果。
AD04 (0.33mg ondansetron taken orally twice daily) acts upon the 5HT3 pathway and is thought to reduce alcohol cravings.
AD04（口服两次每日0.33毫克替硫氧嗪）作用于5HT3通路，据信可以降低酒精渴望。
Post-hoc analyses of Adial's prior clinical studies have indicated that patients with mutations in the 5HT3 receptor experience substantial and clinically meaningful reductions in alcohol consumption.
Adial以前的临床研究的事后分析表明，具有5HT3受体基因突变的患者的酒精消耗量减少显著且具有临床意义。
Furthermore, in both previous clinical trials, AD04 had similar adverse events to placebo, demonstrating that it is safe and tolerable.
此外，在以前的两个临床试验中，AD04与安慰剂的不良事件类似，证明它是安全且耐受的。
Adial has already developed a companion diagnostic test to identify the specific genotypes that benefit from AD04.
Adial已经开发出一种伴侣诊断测试，以识别从AD04中获益的特定基因型。
Price Action: ADIL shares closed at $1.36 on Tuesday.
ADIL股票周二收于1.36美元。