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The first-in-human study of QHRD106 functioning as a safe and effective long-acting kallikrein drug potentially aiding ischemic stroke. QHRD106作为一种安全有效的长效降凝血酶药物,可能有助于缺血性中风,这是首次进行人体研究。
IF 4.9 2区 医学 Q1 PHARMACOLOGY & PHARMACY Pub Date : 2024-11-19 DOI: 10.1080/13543784.2024.2430200
Lei Huang, Runbin Sun, Hengwen Song, Zhiyou Chen, Yuxin Hong, Haoyi Yang, Yuwen Zhang, Lijun Wei, Fei Fei, Juan Li

Background: This study assessed the pharmacokinetics (PK), pharmacodynamics (PD) and safety of QHRD106, and made a comparison with urinary kallindinogenase (UKN) in healthy volunteers.

Methods: This study comprised a randomized, double-blind, placebo-controlled, single-dose escalation phase and an open-label, multiple-dose escalation phase. Ninety-four subjects received intramuscular injections of QHRD106/placebo only once and 30 subjects received QHRD106 four times. Six subjects received 0.15 PNA units UKN intravenously for 7 d. PK and PD analysis were conducted by using a electrochemiluminescent assay and a liquid chromatography/mass spectrometry methodology, respectively. Cerebral circulation was assessed by the magnetic resonance imaging system.

Results: QHRD106 exhibited a slow absorption profile in the human body. Compared to UKN, QHRD106-induced changes in bradykinin concentration later, but with a noticeably prolonged duration. Compared to baseline, cerebral blood flow exhibited a significant improvement on d 7 after a single dose of 18,900 IU and an improvement from d 2 to d 14 after multiple doses of 8400 IU of QHRD106. QHRD106 appeared generally good safety and no severe adverse events occurred in all the groups.

Conclusions: This study provided initial evidence of potential treatment for ischemic strokes that the QHRD106 injection functioned as a safe and effective long-acting kallikrein drug.

Registration: This study was registered on ClinicalTrials.gov with the identifier NCT06380699 and NCT06388772.

背景:本研究评估了QHRD106在健康志愿者中的药代动力学(PK)、药效学(PD)和安全性,并与尿中凯林胰岛素原酶(UKN)进行了比较:该研究包括随机、双盲、安慰剂对照、单剂量递增阶段和开放标签、多剂量递增阶段。94名受试者只接受了一次QHRD106/安慰剂肌肉注射,30名受试者接受了四次QHRD106肌肉注射。PK 和 PD 分析分别采用电化学发光法和液相色谱/质谱法进行。磁共振成像系统对脑循环进行了评估:结果:QHRD106 在人体内的吸收速度较慢。与 UKN 相比,QHRD106 引起缓激肽浓度变化的时间更晚,但持续时间明显更长。与基线相比,单次服用18900 IU后,脑血流量在第7天有明显改善;多次服用8400 IU QHRD106后,脑血流量在第2天至第14天均有改善。QHRD106的安全性总体良好,各组均未出现严重不良反应:这项研究为缺血性脑卒中的潜在治疗提供了初步证据,证明QHRD106注射液是一种安全有效的长效降钙素药物:本研究已在ClinicalTrials.gov上注册,标识符为NCT06380699和NCT06388772。
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引用次数: 0
Promising selective progesterone receptor modulators: what's new in female contraception? 前景看好的选择性孕酮受体调节剂:女性避孕的新动向?
IF 5.4 2区 医学 Q1 PHARMACOLOGY & PHARMACY Pub Date : 2024-11-18 DOI: 10.1080/13543784.2024.2422838
Anita Nelson, Marit Pearlman Shapiro

Introduction: Selective progesterone receptor modulators (SPRMs), such as mifepristone and ulipristal acetate (UPA), have demonstrated high efficacy and safety as single-dose treatments for medication abortion and emergency contraception (EC). Other obstetrical and gynecologic applications have emerged, both for episodic and ongoing uses. The potential of these compounds to provide estrogen-free, ongoing contraception is promising; however, the rare, but serious, hepatic injury cases seen with UPA have put at least a temporary halt to further research in this area.

Areas covered: This paper reviews the biophysical impacts and clinical applications of SPRMs in women's reproductive health, with a focus on the roles of mifepristone and UPA in family planning. Given the political environment, especially in the United States where these applications may be threatened, extensive description is dedicated to mechanisms of action of these agents.

Expert opinion: Both mifepristone and ulipristal acetate are first-line options for single-use applications. There continues to be a need for estrogen-free ongoing contraception that does not have unpopular impacts on bleeding caused by contraceptive methods and for treatments for heavy menstrual bleeding. However, current restrictions on UPA limit longer term use. Perhaps other SPRMs without hepatic impacts may emerge to fill this need.

简介:选择性孕酮受体调节剂(SPRMs),如米非司酮和醋酸乌利司他(UPA),作为药物流产和紧急避孕(EC)的单剂量治疗,已被证明具有很高的有效性和安全性。其他妇产科应用也已出现,既有偶发性应用,也有持续性应用。这些化合物具有提供不含雌激素的持续避孕的潜力,前景广阔;然而,UPA 罕见但严重的肝损伤病例至少暂时停止了这一领域的进一步研究:本文回顾了 SPRM 在妇女生殖健康中的生物物理影响和临床应用,重点关注米非司酮和 UPA 在计划生育中的作用。鉴于目前的政治环境,尤其是在美国,这些药物的应用可能会受到威胁,因此对这些药物的作用机制进行了广泛的描述:专家意见:米非司酮和醋酸乌利司他都是一次性使用的一线选择。人们仍然需要不含雌激素的持续避孕药物,这种药物不会对避孕方法引起的出血造成不受欢迎的影响,也需要治疗大量月经出血的药物。然而,目前对 UPA 的限制限制了其长期使用。也许会出现其他不会对肝脏造成影响的 SPRM 来满足这一需求。
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引用次数: 0
Targeting a key FAK-tor: the therapeutic potential of combining focal adhesion kinase (FAK) inhibitors and chemotherapy for chemoresistant non-small cell lung cancer. 靶向关键的FAK-tor:结合焦点粘附激酶(FAK)抑制剂和化疗治疗化疗耐药非小细胞肺癌的治疗潜力。
IF 4.9 2区 医学 Q1 PHARMACOLOGY & PHARMACY Pub Date : 2024-10-22 DOI: 10.1080/13543784.2024.2417762
Emma Geijerman, Francesca Terrana, Godefridus J Peters, Dongmei Deng, Patrizia Diana, Elisa Giovannetti, Geng Xu

Introduction: NSCLC is the leading cause of cancer-related deaths globally, with a low survival rate primarily due to NSCLC frequently becoming chemoresistant. Focal adhesion kinase (FAK) is a non-receptor tyrosine kinase involved in pathways regulating multiple processes in the cell, including survival, migration, and the TME, that contribute to both tumor progression and drug resistance. Recently, FAK inhibitors (FAKi) have shown promising potential for the treatment of NSCLC.

Areas covered: This narrative review aims to summarize key signaling pathways involving FAK that contribute to tumor progression and drug resistance. It will further provide an overview of FAKi currently in pre- and early-phase clinical trials for solid tumors, as well as the therapeutic potential of combining FAKi with chemotherapy, as this has emerged as a promising strategy to overcome chemoresistance in NSCLC.

Expert opinion: It is becoming increasingly clear that FAK is not an oncogenic driver but rather contributes to tumor progression and drug resistance. Hence, while FAKi have only demonstrated modest results in clinical trials when given by themselves, treatment regimens combining other therapies with FAKi have shown promising potential to overcome drug resistance. Lastly, of particular novelty are FAK-PROTACs (proteolysis-targeting chimaeras), which uniquely target both cytosolic and nuclear FAK.

简介非小细胞肺癌是全球癌症相关死亡的主要原因,其生存率低的主要原因是非小细胞肺癌经常出现化疗耐药。病灶粘附激酶(FAK)是一种非受体酪氨酸激酶,参与调节细胞的多个过程,包括生存、迁移和TME,这些过程都会导致肿瘤进展和耐药性。最近,FAK 抑制剂(FAKi)显示出治疗 NSCLC 的巨大潜力:本综述旨在总结涉及FAK的关键信号通路,这些通路有助于肿瘤的进展和耐药性的产生。它将进一步概述目前正在进行的FAKi治疗实体瘤的前期和早期临床试验,以及FAKi与化疗相结合的治疗潜力,因为这已成为克服NSCLC化疗耐药性的一种有前途的策略:越来越清楚的是,FAK 并非致癌驱动因素,而是导致肿瘤进展和耐药性的因素。因此,虽然FAKi本身在临床试验中的效果一般,但将其他疗法与FAKi相结合的治疗方案却显示出克服耐药性的巨大潜力。最后,FAK-PROTACs(蛋白水解靶向chimaeras)具有特殊的新颖性,可同时靶向细胞膜和细胞核FAK。
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引用次数: 0
Dual blockade of endothelin A and angiotensin II type 1 receptors with sparsentan as a novel treatment strategy to alleviate IgA nephropathy. 用司帕生坦双重阻断内皮素 A 和血管紧张素 II 1 型受体,作为缓解 IgA 肾病的新型治疗策略。
IF 4.9 2区 医学 Q1 PHARMACOLOGY & PHARMACY Pub Date : 2024-10-18 DOI: 10.1080/13543784.2024.2414902
Hajime Nagasawa, Hitoshi Suzuki, Seiji Ueda, Yusuke Suzuki

Introduction: Although immunoglobulin A nephropathy (IgAN) had been discovered more than 50 years ago, 30-40% of IgAN patients still have primary glomerular disease that progresses to end-stage renal disease. However, various treatment strategies for IgAN have rapidly expanded in recent years to include endothelin (ET) receptor antagonists.

Areas covered: In this review, we discuss the role of the ET-1/ETA receptor axis in the development of IgAN, especially focusing on the potential of sparsentan, a dual ET and angiotensin receptor antagonist as a novel therapy for IgAN.

Expert opinion: Evaluation of the MEST-C score at the time of renal biopsy in IgAN is important in determining treatment strategies. If lesions are mainly in the acute phase, such as crescents, steroid therapy should be continued. However, if lesions are mainly in the chronic phase, such as glomerulosclerosis, sparsentan rather than steroid or angiotensin II receptor blocker alone may improve renal outcomes. Although further clinical studies are needed to back up these assumptions, appropriate combination of new drugs containing sparsentan and conventional drugs for IgAN treatment at the appropriate disease stage is expected to further inhibit the progression of renal damage.

简介尽管免疫球蛋白A肾病(IgAN)早在50多年前就已被发现,但仍有30%-40%的IgAN患者患有原发性肾小球疾病,并发展为终末期肾病。然而,近年来IgAN的各种治疗策略已迅速扩展,包括内皮素(ET)受体拮抗剂:在这篇综述中,我们讨论了 ET-1/ETA 受体轴在 IgAN 发病过程中的作用,尤其关注了 sparsentan(一种 ET 和血管紧张素受体双重拮抗剂)作为 IgAN 新型疗法的潜力:专家意见:在 IgAN 肾活检时评估 MEST-C 评分对于确定治疗策略非常重要。如果病变主要发生在急性期,如新月体,则应继续使用类固醇治疗。但是,如果病变主要处于慢性期,如肾小球硬化,则单用司帕生坦而非类固醇或血管紧张素 II 受体阻滞剂可能会改善肾脏预后。尽管还需要进一步的临床研究来支持这些假设,但在适当的疾病阶段,将含有 sparsentan 的新药与用于 IgAN 治疗的传统药物适当结合,有望进一步抑制肾损害的进展。
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引用次数: 0
Management of inflammaging in kidney diseases: focusing on the current investigational drugs. 肾脏疾病的炎症管理:关注当前的研究药物。
IF 4.9 2区 医学 Q1 PHARMACOLOGY & PHARMACY Pub Date : 2024-10-16 DOI: 10.1080/13543784.2024.2417755
Vishwadeep Shelke, Neha Dagar, Maciej Lech, Anil Bhanudas Gaikwad

Introduction: To improve kidney disease treatments, it is crucial to understand how inflammaging affects patients´ longevity. We could potentially slow down kidney disease progression and enhance longevity by targeting specific pathways involved in inflammaging with potential drugs.

Areas of covered: This review offers an updated overview of 'anti-inflammaging' drugs currently in the kidney disease research pipeline, as well as those with potential for future therapeutic use. Furthermore, these drugs are categorized according to their mechanisms, including targeting inflammation, immune and metabolic regulation, oxidative stress, senescence, and autophagy, as demonstrated in preclinical and early clinical trials. Additionally, the review provides insights into key challenges and opinions for future advancements in this field.

Expert opinion: We reviewed recent advancements in applying different therapies to mitigate inflammaging in kidney diseases. We underscore the need for continued research to elucidate the complex pathways underlying inflammaging, which will be essential for the development of more precise and effective treatments. As research in this field advances, several emerging drugs appear promising for future investigation. While current findings are encouraging, further clinical studies are required to validate the therapeutic potential of these agents in kidney diseases, ultimately paving the way for more targeted and efficacious interventions.

导言:为了改善肾脏疾病的治疗,了解炎症如何影响患者的寿命至关重要。我们有可能利用潜在药物靶向参与炎症反应的特定通路,从而减缓肾脏疾病的进展并延长寿命:本综述概述了目前肾脏病研究中的 "抗炎 "药物以及未来有可能用于治疗的药物。此外,这些药物还根据其机制进行了分类,包括针对炎症、免疫和代谢调节、氧化应激、衰老和自噬的药物,这些都在临床前和早期临床试验中得到了证实。此外,本综述还深入探讨了这一领域未来发展所面临的主要挑战和意见:我们回顾了应用不同疗法减轻肾脏疾病炎症反应的最新进展。我们强调有必要继续开展研究,以阐明导致炎症的复杂途径,这对于开发更精确、更有效的治疗方法至关重要。随着该领域研究的不断深入,一些新兴药物似乎很有希望在未来得到研究。虽然目前的研究结果令人鼓舞,但还需要进一步的临床研究来验证这些药物对肾脏疾病的治疗潜力,最终为更有针对性和更有效的干预措施铺平道路。
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引用次数: 0
Protein phosphatase 2A activators under investigation for smoking-related chronic obstructive pulmonary disease and related disorders. 正在研究用于治疗与吸烟有关的慢性阻塞性肺病和相关疾病的蛋白磷酸酶 2A 激活剂。
IF 4.9 2区 医学 Q1 PHARMACOLOGY & PHARMACY Pub Date : 2024-10-15 DOI: 10.1080/13543784.2024.2416982
Sabina Antoniu, Setfan Rascu

Introduction: Chronic obstructive pulmonary disease (COPD) is characterized by progressive inflammation during therapy. Cystic fibrosis (CF), alpha-one antitrypsin deficiency (AATD), and non-CF bronchiectasis are also chronic respiratory disorders with inflammation and progression that share many similarities with COPD. Therefore, various anti-inflammatory approaches are currently being investigated, and protein phosphatase 2A (PP2A) activators may represent one such approach.

Areas covered: Systematic review of papers published from 2000-to date on the anti-inflammatory role of endogenous PP2A, the consequences of its inhibition by smoking, and the beneficial effects of its activation in COPD.

Expert opinion: PP2A activation is a plausible therapeutic approach in COPD and related disorders, such as CF, AATD, and non-CF bronchiectasis, although the available evidence is still mostly experimental. Metformin repurposing and consideration of inhalation for some of the molecules discussed in this study are promising approaches.

简介慢性阻塞性肺病(COPD)的特点是在治疗过程中出现进行性炎症。囊性纤维化(CF)、α-1 抗胰蛋白酶缺乏症(AATD)和非囊性纤维化支气管扩张症也是慢性呼吸系统疾病,其炎症和进展与慢性阻塞性肺病有许多相似之处。因此,目前正在研究各种抗炎方法,而蛋白磷酸酶 2A(PP2A)激活剂可能就是其中一种方法:系统综述 2000 年至今发表的关于内源性 PP2A 的抗炎作用、吸烟抑制 PP2A 的后果以及激活 PP2A 对慢性阻塞性肺病的有益影响的论文:专家观点:PP2A 激活是慢性阻塞性肺病及相关疾病(如 CF、AATD 和非 CF 支气管扩张症)的一种可行治疗方法,尽管现有证据仍主要是实验性的。二甲双胍再利用和考虑吸入本研究中讨论的一些分子是很有前景的方法。
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引用次数: 0
Theranostic strategies in sarcoma: preliminary clinical evidence. 肉瘤的血清疗法策略:初步临床证据。
IF 4.9 2区 医学 Q1 PHARMACOLOGY & PHARMACY Pub Date : 2024-10-09 DOI: 10.1080/13543784.2024.2414119
Luca Filippi, Cristina Ferrari, Giuseppe Rubini

Introduction: Sarcomas encompass a highly diverse range of malignancies, characterized by varied morphological and molecular profiles. Treatment options in case of therapy-refractory or advanced disease are limited. In this context, theranostics emerges as an innovative platform seamlessly integrating diagnosis and therapy, offering promising prospects.

Areas covered: This special report delves into the initial clinical applications of theranostic-based approaches in sarcomas. Specifically, it examines various strategies targeting biomarkers associated with sarcomas, including fibroblast activation protein (FAP), prostate-specific membrane antigen (PSMA), C-X-C chemokine receptor type 4 (CXCR4) and somatostatin receptor 2 (SSTR2).

Expert opinion: The heterogeneous uptake of the CXCR4-targeted radioligand in lesions, along with its poor correlation with immunohistochemistry data, diminishes the attractiveness of this theranostic approach in the sarcoma oncological setting. SSTR2-targeted approaches in sarcoma, although potentially effective, are limited to a single case. Early experiences with FAP inhibitors in sarcoma patients have shown particularly promising outcomes, indicating effective disease control with minimal toxicity. While PSMA presents an enticing target for theranostic approaches in sarcomas, its utilization remains anecdotal and requires further investigation. Prospective and well-designed clinical trials are imperative to delineate the potential impact of FAPI- and PSMA-based approaches on sarcoma therapeutic landscapes, offering innovative and personalized treatment options.

简介肉瘤是一种高度多样化的恶性肿瘤,其形态和分子特征各不相同。治疗难治或晚期疾病的治疗方案有限。在这种情况下,治疗学作为一个将诊断和治疗无缝结合的创新平台应运而生,前景广阔:本特别报告深入探讨了基于治疗仪的方法在肉瘤中的初步临床应用。具体来说,它研究了针对肉瘤相关生物标记物的各种策略,包括成纤维细胞活化蛋白(FAP)、前列腺特异性膜抗原(PSMA)、C-X-C趋化因子受体4型(CXCR4)和体生长激素受体2(SSTR2):专家意见:CXCR4 靶向放射性配体在病变组织中的吸收不均匀,而且与免疫组化数据的相关性较差,这降低了这种治疗方法在肉瘤肿瘤治疗中的吸引力。SSTR2靶向肉瘤的方法虽然可能有效,但仅限于单个病例。在肉瘤患者中使用 FAP 抑制剂的早期经验显示出特别好的疗效,表明能有效控制疾病,且毒性极小。虽然 PSMA 为肉瘤治疗方法提供了一个诱人的靶点,但其应用仍是传闻,需要进一步研究。前瞻性和精心设计的临床试验势在必行,以确定基于 FAPI 和 PSMA 的方法对肉瘤治疗的潜在影响,从而提供创新的个性化治疗方案。
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引用次数: 0
Assessing the clinical potential of plozasiran, an APOC3 siRNA therapy for severe hypertriglyceridemia. 评估 APOC3 siRNA 治疗严重高甘油三酯血症的临床潜力。
IF 4.9 2区 医学 Q1 PHARMACOLOGY & PHARMACY Pub Date : 2024-10-09 DOI: 10.1080/13543784.2024.2414126
Xuan L Tang, Amanda J Hooper, John R Burnett
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引用次数: 0
A four-in-one first-in-human study to assess safety, tolerability, pharmacokinetics, pharmacodynamics, and concentration-QTc relationship of HRS-1780, a selective non-steroidal mineralocorticoid receptor antagonist, in healthy men. 这是一项四合一的首次人体试验,目的是评估 HRS-1780(一种选择性非甾体类矿物质皮质激素受体拮抗剂)在健康男性中的安全性、耐受性、药代动力学、药效学和浓度-QTc 关系。
IF 4.9 2区 医学 Q1 PHARMACOLOGY & PHARMACY Pub Date : 2024-10-01 Epub Date: 2024-08-26 DOI: 10.1080/13543784.2024.2393867
Qi Shen, Lingzhi Li, Weilin Qian, Xue Dong, Manchen Bao, Rong Huang, Na Li, Zi Ye, Gang Cheng, Quanren Wang, Kai Shen, Zhu Luo

Background: This first-in-human study evaluated HRS-1780, an oral selective non-steroidal mineralocorticoid receptor antagonist, in healthy men.

Research design and methods: In single ascending dose (SAD) part, 10 participants for each dose cohort (5, 10, 20, 40, 60, and 80 mg) were randomized (8:2) to HRS-1780 or placebo. In multiple ascending dose part, 12 participants for each dose (10, 20, and 40 mg) were randomized (9:3) to HRS-1780 or placebo once daily for 7 days. The primary endpoint was safety and tolerability.

Results: HRS-1780 was well tolerated with all adverse events being mild. In the steady state, the median time to maximum concentration (Tmax) was 0.750 h and mean half-life was 1.76-1.96 h. High-fat/high-calorie meal prolonged Tmax but did not affect exposure. Multiple dosing of HRS-1780 at 40 mg showed a decreasing trend in systolic blood pressure compared with placebo. Changes in plasma aldosterone and norepinephrine with HRS-1780 were higher compared to placebo. Upper bounds of two-sided 90% confidence interval of placebo-adjusted change-from-baseline QTcF were below 10 msec at the maximum concentration in SAD. The trial had limited sample size and short study duration.

Conclusions: HRS-1780 had favorable safety and pharmacokinetic profiles and did not cause clinically meaningful QTcF prolongation.

Trial registration: ClinicalTrials.gov (NCT05638126).

研究背景这项首次人体研究评估了健康男性口服选择性非甾体类矿化皮质激素受体拮抗剂HRS-1780的疗效:在单次递增剂量(SAD)部分,每个剂量组群(5、10、20、40、60和80毫克)的10名参与者被随机(8:2)分配到HRS-1780或安慰剂中。在多剂量递增部分,每个剂量组(10、20和40毫克)的12名参与者以9:3的比例随机接受HRS-1780或安慰剂治疗,每天一次,连续治疗7天。主要终点是安全性和耐受性:结果:HRS-1780耐受性良好,所有不良反应均较轻微。稳态时,达到最大浓度(Tmax)的中位时间为0.750小时,平均半衰期为1.76-1.96小时。高脂肪/高热量膳食会延长Tmax,但不会影响暴露量。与安慰剂相比,多次服用40毫克HRS-1780后收缩压呈下降趋势。与安慰剂相比,HRS-1780 对血浆醛固酮和去甲肾上腺素的影响更大。在SAD的最大浓度下,安慰剂调整后的基线QTcF变化的双侧90%置信区间上限低于10毫秒。该试验的样本量有限,研究持续时间较短:HRS-1780具有良好的安全性和药代动力学特征,不会导致有临床意义的QTcF延长:试验注册::ClinicalTrials.gov (NCT05638126)。
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引用次数: 0
The first-in-human study to assess the safety, tolerability, pharmacokinetics, and pharmacodynamics of the factor XI monoclonal antibody SHR-2004 in healthy subjects. 首次在健康受试者中开展人体研究,评估因子 XI 单克隆抗体 SHR-2004 的安全性、耐受性、药代动力学和药效学。
IF 4.9 2区 医学 Q1 PHARMACOLOGY & PHARMACY Pub Date : 2024-10-01 Epub Date: 2024-08-22 DOI: 10.1080/13543784.2024.2391837
Tingting Ma, Zuyi Weng, Bei Cao, Yanli Dong, Chanjuan Deng, Lei Huang, Yuanxun Yang, Yuqi Wang, Chenxi Shen, Lei Wang, Kai Shen, Juan Li

Background: Inhibiting the coagulation factor XI (FXI) is a novel strategy for prevention and treatment of thromboembolism without affecting extrinsic coagulation pathways. SHR-2004 is a humanized monoclonal antibody that selectively binds to FXI and factor XIa (FXIa).

Research design & methods: This randomized, double-blind, dose-escalation, placebo-controlled study evaluated SHR-2004 administered either intravenously (i.v.; Part A) or subcutaneously (s.c.; Part B). In Part A, 24 subjects received a single i.v. dose of SHR-2004 (0.1, 0.3, or 1.0 mg/kg) or placebo. In Part B, 40 subjects received a single s.c. dose of SHR-2004 (0.5, 1.0, 3.0, or 4.5 mg/kg) or placebo.

Results: SHR-2004 was well tolerated. Plasma exposure to SHR-2004 increased in a dose-dependent manner. The geometric mean half-time ranged from 11.6 to 13.0 days. FXI activity decreased, and the activated partial thromboplastin time (APTT) was prolonged after i.v. and s.c. administration in a dose- and time-dependent manner. FXI activity was nearly completely abolished immediately after administering the highest i.v. dose, with the average APTT prolonged to nearly three times of baseline.

Conclusion: SHR-2004 is a promising candidate for further development as an anticoagulant drug that exerts effective anticoagulation with minimal risk of bleeding.

Clinical trial registration: www.clinicaltrials.gov identifier is NCT05369767.

背景:抑制凝血因子 XI (FXI) 是预防和治疗血栓栓塞症的一种新策略,但不会影响外源性凝血途径。SHR-2004是一种选择性结合FXI和因子XIa(FXIa)的人源化单克隆抗体:这项随机、双盲、剂量递增、安慰剂对照研究评估了静脉注射(i.v. ;A 部分)或皮下注射(s.c. ;B 部分)SHR-2004。在 A 部分,24 名受试者接受了单次静脉注射 SHR-2004(0.1、0.3 或 1.0 毫克/千克)或安慰剂。在 B 部分中,40 名受试者接受单次静脉注射 SHR-2004(0.5、1.0、3.0 或 4.5 毫克/千克)或安慰剂:结果:SHR-2004 的耐受性良好。SHR-2004 的血浆暴露量呈剂量依赖性增加。几何平均半衰期为 11.6 至 13.0 天。静脉注射和皮下注射后,FXI 活性降低,活化部分凝血活酶时间(APTT)延长,且呈剂量和时间依赖性。静脉注射最高剂量后,FXI 活性几乎完全消失,平均 APTT 延长至基线的近三倍:结论:SHR-2004 是一种有希望进一步开发的抗凝药物,它能发挥有效的抗凝作用,同时将出血风险降到最低。临床试验注册:www.clinicaltrials.gov 识别码为 NCT05369767。
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引用次数: 0
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Expert opinion on investigational drugs
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