SSS40 A Single-center, Randomized, Double-blind, Placebo-controlled Phase I Clinical Study of Single-dose, Dose-escalation Safety, Tolerability, Pharmacokinetics, and Immunogenicity in Healthy Chinese Subjects.

This is a single-center, randomized, double-blind, single-administration, escalating-dose, placebo-controlled, phase I clinical trial to evaluate the safety, tolerability, pharmacokinetics, and immunogenicity of SSS40 in healthy subjects in China.
A total of 8 subcutaneous dose groups were planned, including 1mg, 3mg, 10mg, 20mg, 30mg, 45mg, 60mg, 80mg. Starting from the 10mg group, a sentinel approach was adopted, whereby 2 subjects were first enrolled in the group, and randomized to the sentinel group in a 1:1 ratio (test drug:placebo), with the sentinels blinded, and then the remaining subjects in the group were randomized according to a 1:1 ratio (test drug:placebo), and the sentinel group was blinded. After completion of the 72-h safety assessment in the sentinel group, the remaining subjects in the group were randomized to receive the drug according to the test drug group and the placebo group.

开始日期2023-08-28

申办/合作机构

青岛大学附属医院

CTR20232318 / Active, not recruiting临床1期

SSS40在中国健康受试者中的单次给药、剂量递增的安全性、耐受性、药代动力学及免疫原性研究的单中心、随机、双盲、安慰剂对照的I期临床研究

主要目的：评估SSS40在中国健康受试者中的安全性和耐受性。次要目的： 1)评估SSS40单次给药后在中国健康受试者中的药代动力学（PK）特征； 2)评估SSS40单次给药后在中国健康受试者中的免疫原性。

开始日期2023-08-28

申办/合作机构

沈阳三生制药有限责任公司

100 项与人源化神经生长因子抗体（沈阳三生制药）相关的临床结果

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100 项与人源化神经生长因子抗体（沈阳三生制药）相关的转化医学

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100 项与人源化神经生长因子抗体（沈阳三生制药）相关的专利（医药）

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项与人源化神经生长因子抗体（沈阳三生制药）相关的文献（医药）

2023-07-01·Clinical Drug Investigation

Peripheral Nerve Safety of Nerve Growth Factor Inhibition by Tanezumab: Pooled Analyses of Phase III Clinical Studies in Over 5000 Patients with Osteoarthritis

Article

作者: Koltzenburg, Martin ; Gorson, Kenneth C ; Hickman, Anne ; Brown, Mark T ; Gaitonde, Puneet ; Cornblath, David R ; Pixton, Glenn C ; West, Christine R ; Viktrup, Lars

BACKGROUNDTanezumab, a humanized anti-nerve growth factor antibody, was developed for the treatment of pain associated with osteoarthritis. Due to its mechanism of action, peripheral nerve safety was assessed in all clinical studies.OBJECTIVESTo summarize the neurological safety of intravenous (IV) and subcutaneous (SC) tanezumab versus placebo in patients with osteoarthritis.METHODSData were pooled from 3389 patients across seven studies that investigated IV administration, and from 1840 patients across three studies that investigated SC administration. The treatment period of each study ranged from 16 to 24 weeks, and follow-up periods ranged from 8 to 24 weeks. Neurological safety evaluations focused on adverse events (AEs) of abnormal peripheral sensation (APS), neurologic examinations, and consultations.RESULTSAcross datasets, the incidence of AEs of APS was higher in tanezumab groups versus placebo. Paresthesia and hypoesthesia were the most frequently reported AEs in tanezumab-treated patients, compared with placebo. In both datasets, most AEs were of mild severity, resolved, and rarely resulted in discontinuation. In all treatment groups in both IV and SC studies, over 90% of patients had no new or worsened neurological examination abnormalities at the last study visit. Across datasets, mononeuropathy was diagnosed more frequently in tanezumab groups compared with placebo. Polyneuropathy was diagnosed in ≤ 0.9% of patients in tanezumab and placebo groups.CONCLUSIONSTanezumab IV or SC had an increased incidence of AEs of APS, such as paresthesia and hypoesthesia, and diagnoses of mononeuropathy compared with placebo. However, tanezumab was not associated with generalized peripheral neuropathy.CLINICALTRIALSGOV IDENTIFIERSNCT00733902, NCT00744471, NCT00830063, NCT00863304, NCT00863772, NCT01089725, NCT00985621, NCT02697773, and NCT02709486.

2022-07-01·FEBS Open Bio4区 · 生物学

Analgesic effects of nerve growth factor‐directed monoclonal antibody on diabetic neuralgia in an animal model

4区 · 生物学

ArticleOA

作者: Li, Santai ; Wang, Guifeng ; Wang, Chunhe ; Chen, Yi‐Li ; Li, Huanhuan ; Chen, Ganjun ; Dong, Xingchen ; Wang, Qi ; Tan, Jie ; Xie, Zuobin ; Pei, Min

Current treatment options for diabetic neuralgia are limited and unsatisfactory. Tanezumab, a monoclonal antibody that blocks nerve growth factor (NGF) signaling, has been shown to be effective in relieving the clinical symptoms of osteoarthritis pain, chronic low back pain, cancer pain induced by bone metastasis, and diabetic neuralgia. However, the clinical development of tanezumab has been terminated due to the risk of induction of rapidly progressive osteoarthritis (RPOA), and no other NGF antibodies have been examined for their ability to treat diabetic neuralgia in either animal models or clinical trials. In this study, a humanized high‐affinity NGF monoclonal antibody (mAb), huAb45 that could neutralize the interaction between NGF and its high‐affinity receptor TrkA. In a mouse diabetic neuralgia model, it effectively relieved neuropathic pain. This study may serve as the necessary foundation for future studies of huAb45 to potentially treat diabetic neuralgia.

2021-02-01·Expert Opinion on Investigational Drugs2区 · 医学

The time to develop treatments for diabetic neuropathy

2区 · 医学

Review

作者: Rendell, Marc S.

BACKGROUNDDiabetic neuropathy is a multifaceted condition affecting up to 50% of individuals with long standing diabetes. The most common presentation is peripheral diabetic sensory neuropathy (DPN).METHODSWe carried out a systematic review of papers dealing with diabetic neuropathy on Pubmed in addition to a targeted Google search.Search terms included small fiber neuropathy,diffuse peripheral neuropathy, quantitative sensory testing, nerve conduction testing, intra-epidermal nerve fiber density, corneal confocal reflectance microscopy, aldose reductase inhbitors, nerve growth factor, alpha-lipoic acid, ruboxistaurin, nerve growth factor antibody, and cibinetide.RESULTSOver the past half century, there have been a number of agents undergoing unsuccessful trials for treatment of DPN.There are several approved agents for relief of pain caused by diabetic neuropathy, but these do not affect the pathologic process.EXPERT OPINIONThe failure to find treatments for diabetic neuropathy can be ascribed to (1) the complexity of design of studies and (2) the slow progression of the condition, necessitating long duration trials to prove efficacy.We propose a modification of the regulatory process to permit early introduction of agents with demonstrated safety and suggestion of benefit as well as prolongation of marketing exclusivity while long term trials are in progress to prove efficacy.

项与人源化神经生长因子抗体（沈阳三生制药）相关的新闻（医药）

2023-01-08

·药渡Daily

4款1类新药首次获批临床！涉及智翔金泰、豪森药业等

2023年1月6日，根据国家药品监督管理局药品审评中心（CDE）最新数据显示，CDE官网新增了7款1类新药的默示许可信息（不含补充申请）。经过梳理，这些1类新药适应症涉及破伤风、哮喘、肾病、疼痛等，靶点涉及Tetanus toxin、TSLP、NGF等。破伤风类毒素抑制剂单抗：GR2001注射液01GR2001注射液是智翔金泰开发的一款创新破伤风类毒素抑制剂单抗，本次临床默示许可适应症为预防破伤风，这是该药在国内首次获批临床。破伤风是由破伤风梭菌引起的急性感染性、中毒性疾病，在无医疗干预的情况下，尤其是老年人和婴幼儿，病死率接近100%。即使经过积极的综合治疗，该病的病死率在全球范围仍为30-50%。GR2001注射液获批临床，在预防治疗破伤风领域有着不错的潜力。吸入式TSLP纳米抗体：LQ043H单域抗体雾化液02LQ043H单域抗体雾化液是洛启生物自主研发的靶向TSLP的吸入式纳米抗体药物，本次临床默示许可适应症为用于治疗中重度哮喘，这是该药在国内首次获批临床。抑制人胸腺基质淋巴细胞生成素（TSLP）在近期的临床研究中被证实是一种有效治疗非嗜酸性及嗜酸性粒细胞哮喘的有效方式。TSLP由气道上皮细胞分泌，被认为是“上游”细胞因子，可激活DC并释放趋化因子，从而募集并激活Th2细胞；TSLP也可能通过作用于肺成纤维细胞而参与气道壁重塑。截至目前，哮喘仍是世界公认的医学难题，被世界卫生组织列为疾病中的四大顽症之一，是仅次于癌症的世界第二大致死和致残疾病。全球约有3.5亿人患有哮喘，其中约有10%-15%为重度患者，存在巨大的临床需求。哮喘的用药包括静脉、皮下、口服和吸入等方式，其中吸入给药是最佳的给药方式。LQ036的吸入给药方式将极大的方便患者用药，是全球为数不多的吸入式治疗哮喘的抗体新药。LQ036正在澳大利亚开展I期临床，主要考察LQ036在健康人和哮喘患者中的安全性、耐受性、药代动力学等，目前无任何药物相关不良反应发生，LQ036呈现出优异的安全性。数据来源：美国临床试验注册中心HS-10390片03HS-10390片是豪森药业开发的一款创新1类化药，靶点尚不明确，本次临床默示许可适应症为局灶节段性肾小球硬化和免疫球蛋白A肾病，这是该药在国内首次获批临床。局灶性节段性肾小球硬化症（FSGS）是一种常见的肾病综合征，约占原发性肾病综合征的20%~25%，总体的1/6。本病可见于任何年龄，以儿童及青少年尤为多见，平均发病年龄为21岁，极少数的中年人也会患上这种疾病，并且其存在种族差异，在黑色人种中更为普遍。免疫球蛋白A肾病（IgAN）是一种自身免疫性疾病，可引起肾功能衰竭，严重影响患者生活质量并缩短寿命。与非亚裔相比，IgAN在亚裔人群中更常见，且症状出现的时间更早，疾病进展的速度更快，属于严重危及生命且影响生存质量的疾病。高达30-45%的患者因未能获得有效治疗而进展至终末期肾病，不得不接受肾移植及透析等肾脏替代治疗，给患者本人及整个社会带来沉重的医疗负担。HS-10390片在国内获批临床，有望给局灶节段性肾小球硬化和免疫球蛋白A肾病患者带来新的治疗选择，期待该药的未来进展。NGF抗体：人源化神经生长因子抗体注射液04人源化神经生长因子抗体注射液是三生制药开发的一款新型非阿片类止痛抗体新药药，属于神经生长因子（NGF）抑制剂，本次临床默示许可适应症为用于治疗骨转移癌痛，这是该药在国内首次获批临床。NGF是介导急性和慢性疼痛的关键调节因子，靶向NGF的抗体类药物不需要穿过血脑屏障。这种全新的作用机制，有望帮疼痛患者摆脱止痛药成瘾。长期以来，各大药企大量投入开发具有高特异性和亲和力的抗NGF单克隆抗体，其中研究进展最快的是Tanezumab (Pfizer/EliLilly)和Fasinumab (Regeneron/Teva)。虽然此类药物开发过程中有诸多波折，美国FDA和欧洲EMA因为膝关节损失和交感神经元损失等副作用的增加，都拒绝了Tanezumab的上市申请。但通过对剂量和安全性的不断摸索和审查，FDA又重新开放了NGF抗体的临床研究。预计到2028年，该类药物的销售额将达到77亿美元。三生制药开发NGF抗体用于骨转移癌痛，属于国内布局该领域为数不多的玩家之一。其他布局该领域的国产企业有达石药业、康方生物、苑东生物、泰诺麦博等企业，期待这些企业在NGF抗体领域的表现，为国内饱受慢性疼痛的患者带来更为安全有效的治疗方法。往期推荐6款1类新药获批临床！涉及石药集团、博安生物等企业6款国产1类新药获批临床！涉及贝达药业、石药集团等企业5款1类肿瘤新药国内首次获批临床！涉及多禧生物、信立泰等企业👇关注药渡数据媒体矩阵

临床1期临床申请

100 项与人源化神经生长因子抗体（沈阳三生制药）相关的药物交易

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