Aprepitant

一、题目与背景信息 一项在结节性痒疹成人受试者中评价HDM3010的安全性、耐受性、药代动力学和初步疗效的随机、双盲、赋形剂对照、多中心的I/II期临床研究 【适应症】：结节性痒疹 二、临床试验信息 【患者获益】 1.迅速帮助患友找到合适的新药临床机会 2.临床期间无需承担相关的检查费用 3.为患友就近安排大三甲医院 4.由临床医院的专业医疗团队跟踪全程患友诊疗 5.患友获得临床补助：（具体以中心知情为准） 交通补助：200元/次，5-7次; 采血补助：200元/次，14次 【试验周期】 8周，访视共6次;需要住院; 【试验分组】 试验药 1中文通用名:HDM3010；英文通用名:/；商品名称:NA；剂型:凝胶剂；规格:1.5%（10g：150mg）；用法用量:队列1：外用，QD； 队列2和队列3：外用，BID；用药时程:双盲期4周：队列1、2随机至试验组的受试者将接受阳性药物的治疗；开放期4周：结束双盲期的队列1、2受试者选择参与第二阶段的将全部接受阳性药物治疗；4+4周：队列3在整个治疗期间都将接受阳性药物的治疗（开放期可选） 对照药 1中文通用名:HDM3010安慰剂（赋形剂）；英文通用名:/；商品名称:NA；剂型:凝胶剂；规格:10g/支；用法用量:队列1：外用，QD； 队列2和队列3：外用，BID；用药时程:双盲期4周：队列1、2随机至对照组的受试者将接受赋形剂使用。 【入选标准】 1签署知情同意书时，受试者年龄为18-65岁（含界值），性别不限 2筛选时皮肤科专科医生临床诊断PN≥3个月且需同时满足以下标准：筛选期和基线时至少两个体表区域（例如左下肢和右下肢）存在瘙痒结节且分布在双下肢和/或双上肢和/或躯干双侧；b)筛选期和基线时IGA PN-S ≥2（可触及的瘙痒性结节个数≥6个，头皮、面部和掌心除外）；c)基线时过去一周PN相关的WI-NRS周平均值≥7（7天中，要求至少要有4天的评分用于基线平均分计算。如果原计划随机化日期前7天中，患者的报告天数低于4天，应推迟随机化，直至符合要求，但不得超出筛选的最长期限28天） 3筛选期和基线时累及身体表面积（BSA）（头皮除外）：队列1和队列2应＜20%，队列3应≥25% 4筛选期时，有生育能力的女性（WOCBP）受试者血清妊娠试验阴性且基线访视时，尿妊娠试验阴性。WOCBP受试者和未接受输精管结扎术的男性受试者须同意在整个研究期间采取至少一项可靠的避孕措施，包括：口服/植入/注射/经皮避孕药、宫内节育器、双侧输卵管结扎术或双侧输卵管阻塞术、输精管结扎术等。如果应用屏障类避孕措施（如：男用避孕套、女用避孕套），需选择至少一种并正确且性生活中全程使用。如果该受试者常规生活中是禁欲的，那么该受试者可以应用此方式避孕，但当其不再禁欲时，需选择一种上述提及的可靠的避孕方式。男性受试者在研究药物首次给药至末次给药后3个月内不能捐献精子 5充分了解试验内容与可能出现的不良反应后，受试者自愿参加试验，已签署知情同意书 【排除标准】 1筛选和基线时存在其他可能干扰疗效评估或造成瘙痒的疾病，如未受控制的糖尿病或甲状腺疾病、胆汁淤积性肝病、终末期肾病、缺铁性贫血等；或药物（如阿片类药物、血管紧张素转换酶抑制剂[ACEI]）导致的或继发于神经病变或精神疾病的PN 2筛选期或基线前3个月内存在活动性的特应性皮炎（AD）病损或经研究者判断受试者存在除PN以外的可能干扰研究评估的其他皮肤合并症（如皮肤真菌病、银屑病、疥疮、慢性单纯性苔藓、慢性光化性皮炎、疱疹样皮炎和接触性皮炎等） 3随机前接受以下任何一种治疗：既往曾接受过系统性JAK抑制剂治疗或随机前3个月接受过任何外用JAK抑制剂；随机前2周内接受过局部辣椒素、焦油类药物、外用水杨酸类药物、外用维A酸类药物、外用维生素D3类似物、复方利多卡因乳膏、外用磷酸二酯酶-4（PDE-4）抑制剂（例如克立硼罗）、外用抗组胺药、外用皮质类固醇（TCS）、外用钙调磷酸酶抑制剂（TCI）、含有明确有效止痒成分的润肤剂、外用中成药或草药治疗等；随机前4周接受过系统性糖皮质激素、系统性免疫抑制疗法/免疫调节疗法（例如环孢素、甲氨蝶呤、硫唑嘌呤、吗替麦考酚酯、PDE-4抑制剂、干扰素γ[IFN-γ]靶点药物）、沙利度胺、羟氯喹和神经激肽-l（NK-1）受体拮抗剂（如阿瑞匹坦）、阿片受体拮抗剂以及其他可能影响PN疗效评估的其他药物（如抗抑郁药等）；随机前2周内接受过口服抗组胺药；随机前4周内接受过加巴喷丁、普瑞巴林、系统性中成药（如复方甘草酸苷片、雷公藤多苷片）；随机前12周内或5个药物半衰期内（如果已知）（以较长者为准）使用其他免疫调节类生物制剂（如度普利尤）；随机前4周内接受过病灶内皮质类固醇注射和冷冻疗法、光疗；随机前4周内接种过任何活疫苗、减毒活疫苗，或计划在研究期间接种活疫苗、减毒活疫苗；随机前2周或5个半衰期内（以较长者为准）接受过系统性强效细胞色素P450 3A4抑制剂或CYP2C9/3A4双重抑制剂（如氟康唑） 4既往人类免疫缺陷病毒（HIV）感染或可疑感染或筛选时HIV抗体阳性；或乙型肝炎阳性（乙型肝炎病毒表面抗原[HBsAg]阳性或HBsAg阴性但乙型肝炎病毒核心抗体[HBcAb]阳性，需检测HBV-DNA定量，结果高于检测正常值上限）；或丙型肝炎（丙型肝炎病毒[HCV]抗体阳性且加做HCV-RNA定量结果高于正常值上限）；或梅毒筛查阳性（特异性抗体检测阳性，非特异性抗体检测阴性且结合临床判断确证为非活动期感染者除外） 5筛选时可能存在活动性结核感染情况，或有活动性结核病史，或筛选期时胸片联合T-spot筛查（若胸片可疑结核加做胸部CT），提示潜伏或可疑结核 6筛选前3个月内有带状疱疹或明显的水痘-带状疱疹等疱疹病毒感染史 7本研究首次用药前7天内有活动性感染需要使用口服或静脉抗生素、抗真菌药或抗病毒药 8筛选访视前6个月内有寄生虫感染史、疑似寄生虫感染或使用过抗寄生虫药物 9本研究首次用药前5年内患有癌症（恶性肿瘤患者已行根治术5年以上，目前明确无复发或转移的患者除外；已经接受过根治性治疗的非黑色素瘤皮肤癌、局限性前列腺癌、I期子宫内膜癌、宫颈原位癌或乳腺原位癌等除外） 10筛选期或基线时血常规存在以下任何一种异常：白细胞＜3.0 × 10^9/L；中性粒细胞低于正常值下限（LLN）;淋巴细胞＜0.8 × 10^9/L；血红蛋白＜10 g/dL；血小板＜100 × 10^9/L 11筛选时重度肝功能受损（Child-Pugh C级）或终末期肾病或需要透析的肾病或筛选时存在以下指标异常之一：天门冬氨酸氨基转移酶（AST）或丙氨酸氨基转移酶（ALT）＞1.5×正常值上限（ULN）;血清肌酐（SCr）＞正常值上限 12任何研究者认为不适合入组的情况，包括但不限于：已知或怀疑有免疫缺陷病史；有临床意义或未受控制的心血管病变，包括不稳定的心绞痛；筛选前12个月内发生过急性心肌梗死；纽约心脏协会III级或IV级充血性心力衰竭，以及需要治疗的心律失常或未受控制的高血压（静息时收缩压≥160 mmHg和/或舒张压≥100 mmHg）等；有血栓病史，包括深静脉血栓和肺栓塞者；既往或筛选时存在精神疾病或因精神疾病住院（经研究者判断，稳定且轻度的不需要药物治疗的焦虑和/或抑郁除外，且基线医院焦虑抑郁量表[HADS]评分≤10分）；筛选前6个月内有酒精或药物滥用情况；随机前12周内接受过或研究期间计划接受重大手术（定义参照2022年12月06日国家卫健委发布的《医疗机构手术分级管理办法》中规定的3级和4级手术） 13目前正在参加任何其他干预性临床试验；或本研究首次用药前3个月内参加过干预性临床试验 14妊娠期或哺乳期女性，或研究期间及研究结束后3个月内有妊娠或哺乳计划的受试者 15已知对HDM3010成分或乳膏辅料过敏的受试者 参与流程: 1.门诊病例（≥3个月） 2.皮损照片 3.既往用药记录 三、参研中心 1中国医学科学院北京协和医院 2太原市中心医院 3四川大学华西医院 4首都医科大学附属北京同仁医院 5中南大学湘雅医院 6南方医科大学皮肤病医院 7山西医科大学第一医院 8成都市第二人民医院 9重庆医科大学附属第二医院 10复旦大学附属华山医院 11安徽医科大学第二附属医院 12杭州市第一人民医院 13浙江省人民医院 14皖南医学院第二附属医院 15广西中医药大学附属瑞康医院 参与临床试验，获取国际前沿新药免费使用机会！更有一线专家团队为你的治疗保驾护航！ 【雨露招募】目前有脂肪肝、银屑病、特应性皮炎、类风湿性关节炎、强直性脊柱炎、高血压、高血脂、糖尿病、血小板减少症、阿尔茨海默症、溃疡性结肠炎、系统性红斑狼疮、哮喘、青光眼、黄斑变性、慢阻肺、间质性肺病、肺纤维化、肾阳虚、尿路感染、泪沟凹陷、斑秃、雄秃、阴道炎、荨麻疹......等慢病临床试验正在招募患者！ 扫描下方二维码，添加微信完成报名，请备注所患疾病、所在省份城市；审核通过就近安排大三甲医院参与临床试验。 【重要提示】文章信息仅供参考，具体治疗谨遵医嘱！ 临床招募：林老师（19290137703）同微信

Under the new entitlement agreement, Hoth Therapeutics secures annual NVIDIA AI Enterprise Essentials licenses to support its GPU-powered infrastructure, enabling advanced machine learning and neural network modeling capabilities for pharmaceutical research NEW YORK, Oct. 8, 2025 /PRNewswire/ -- Hoth Therapeutics, Inc. (NASDAQ: HOTH), a clinical-stage biopharmaceutical company focused on developing innovative therapies for dermatological, oncological disorders, today announced it has expanded its artificial intelligence (AI) initiative through a new NVIDIA AI Enterprise subscription license to accelerate data-driven drug development, preclinical modeling, and predictive analytics. Under the new entitlement and renewal agreement, Hoth Therapeutics has secured annual NVIDIA AI Enterprise Essentials licenses to support its GPU-powered infrastructure, enabling advanced machine learning and neural network modeling capabilities for pharmaceutical research. "Our continued investment in NVIDIA's AI platform reflects our long-term commitment to integrating next-generation technology across our R&D programs," said Robb Knie, CEO of Hoth Therapeutics. "We are harnessing NVIDIA's enterprise-grade AI infrastructure to accelerate the development of therapies like HT-001, HT-KIT, and our oncology programs — ultimately allowing us to make smarter, faster, and more precise decisions for patients." The NVIDIA AI Enterprise environment will allow Hoth's scientific and data teams to: Deploy predictive pharmacology and toxicity models to enhance compound screening efficiency. Integrate multi-omic and patient-derived data for improved target discovery. Support clinical trial simulation, patient stratification, and real-time response monitoring. Leverage secure GPU-accelerated cloud infrastructure with enterprise-grade reliability and compliance. Hoth's AI initiative complements its broader strategy of digital transformation and innovation in biotechnology, enabling partnerships with advanced AI-driven platforms and life-science data companies to optimize development timelines, reduce costs, and improve therapeutic outcomes. About Hoth Therapeutics, Inc. Hoth Therapeutics is a clinical-stage biopharmaceutical company dedicated to developing innovative, impactful, and ground-breaking treatments with a goal to improve patient quality of life. We are a catalyst in early-stage pharmaceutical research and development, elevating drugs from the bench to pre-clinical and clinical testing. Utilizing a patient-centric approach, we collaborate and partner with a team of scientists, clinicians, and key opinion leaders to seek out and investigate therapeutics that hold immense potential to create breakthroughs and diversify treatment options. To learn more, please visit . Forward-Looking Statement This press release includes forward-looking statements based upon Hoth's current expectations, which may constitute forward-looking statements for the purposes of the safe harbor provisions under the Private Securities Litigation Reform Act of 1995 and other federal securities laws, and are subject to substantial risks, uncertainties, and assumptions. These statements concern Hoth's business strategies; the timing of regulatory submissions; the ability to obtain and maintain regulatory approval of existing product candidates and any other product candidates we may develop, and the labeling under any approval we may obtain; the timing and costs of clinical trials, and the timing and costs of other expenses; market acceptance of our products; the ultimate impact of the current coronavirus pandemic, or any other health epidemic, on our business, our clinical trials, our research programs, healthcare systems, or the global economy as a whole; our intellectual property; our reliance on third-party organizations; our competitive position; our industry environment; our anticipated financial and operating results, including anticipated sources of revenues; our assumptions regarding the size of the available market, benefits of our products, product pricing, and timing of product launches; management's expectation with respect to future acquisitions; statements regarding our goals, intentions, plans, and expectations, including the introduction of new products and markets; and our cash needs and financing plans. There are a number of factors that could cause actual events to differ materially from those indicated by such forward-looking statements. You should not place reliance on these forward-looking statements, which include words such as "could," "believe," "anticipate," "intend," "estimate," "expect," "may," "continue," "predict," "potential," "project" or similar terms, variations of such terms, or the negative of those terms. Although the Company believes that the expectations reflected in the forward-looking statements are reasonable, the Company cannot guarantee such outcomes. Hoth may not realize its expectations, and its beliefs may not prove correct. Actual results may differ materially from those indicated by these forward-looking statements as a result of various important factors, including, without limitation, market conditions and the factors described in the section titled "Risk Factors" in Hoth's most recent Annual Report on Form 10-K and Hoth's other filings made with the U. S. Securities and Exchange Commission. All such statements speak only as of the date made. Consequently, forward-looking statements should be regarded solely as Hoth's current plans, estimates, and beliefs. Investors should not place undue reliance on forward-looking statements. Hoth cannot guarantee future results, events, levels of activity, performance, or achievements. Hoth does not undertake and specifically declines any obligation to update, republish, or revise any forward-looking statements to reflect new information, future events, or circumstances or to reflect the occurrences of unanticipated events, except as may be required by applicable law. Investor Contact: LR Advisors LLC Email: [email protected] Phone: (678) 570-6791 SOURCE Hoth Therapeutics, Inc. WANT YOUR COMPANY'S NEWS FEATURED ON PRNEWSWIRE.COM? 440k+ Newsrooms & Influencers 9k+ Digital Media Outlets 270k+ Journalists Opted In GET STARTED