更新于：2024-06-20
Zamerovimab/Mazorelvimab
泽美洛韦/玛佐瑞韦单抗
更新于：2024-06-20
概要
基本信息
原研机构 |
在研机构 |
最高研发阶段批准上市 |
首次获批日期 中国 (2024-06-04), |
最高研发阶段(中国)批准上市 |
特殊审评孤儿药 (美国) |
登录后查看首次获批时间轴
序列信息
Sequence Code 616722295H
当前序列信息引自: *****
Sequence Code 616722296L
当前序列信息引自: *****
Sequence Code 616723707H
当前序列信息引自: *****
Sequence Code 616723708L
当前序列信息引自: *****
关联
8
项与 泽美洛韦/玛佐瑞韦单抗 相关的临床试验评价重组抗狂犬病毒人源化单克隆抗体注射液（SYN023）与狂犬病疫苗联合用于Ⅲ级狂犬病暴露后人群的有效性和安全性的随机、双盲、阳性对照（HRIG）Ⅲ期临床试验
A Phase III Randomized Blinded Study to Evaluate SYN023 Compared to Human Rabies Immune Globulin in Post Exposure Prophylaxis of Rabies in Adults With Category III Rabies Exposure Risks
A Phase 2b Randomized Blinded Study to Evaluate SYN023 Compared to Human Rabies Immune Globulin in Post Exposure Prophylaxis of Rabies in Adults with Different Rabies Exposure Risks
100 项与 泽美洛韦/玛佐瑞韦单抗 相关的临床结果
登录后查看更多信息
100 项与 泽美洛韦/玛佐瑞韦单抗 相关的转化医学
登录后查看更多信息
100 项与 泽美洛韦/玛佐瑞韦单抗 相关的专利（医药）
登录后查看更多信息
5
项与 泽美洛韦/玛佐瑞韦单抗 相关的文献（医药）2021-09-01Vaccine3区 · 医学
Rabies virus neutralizing activity, pharmacokinetics, and safety of the monoclonal antibody mixture SYN023 in combination with rabies vaccination: Results of a phase 2, randomized, blinded, controlled trial
3区 · 医学
Article
作者: Chuang, Ariel ; Moore, Susan M ; Reid, Caroline ; McClain, J Bruce ; Tsao, Eric
BACKGROUND:
SYN023-002 is a randomized, blinded, controlled study comparing rabies virus neutralizing activity (RVNA) and safety of SYN023, a monoclonal anti-rabies antibody mixture, to human-serum derived anti-rabies immunoglobulin (RIG) when administered with commercially available vaccines to healthy adult volunteers.
METHODS:
Participants were randomized among 4 treatment groups (SYN023 + Imovax, SYN023 + RabAvert, HyperRab + Imovax, HyperRab + RabAvert). On Day 0, subjects received 1 dose of RIG (0.3 mg/kg SYN023 or 20 IU/mL HyperRab) and their first of 5 vaccine doses. The primary objective was to compare cumulative RVNA between SYN023 and HyperRab recipients. Secondary objectives were to compare safety and to assess SYN023 pharmacokinetics and immunogenicity.
RESULTS:
All 164 randomized subjects initiated treatment and were included in safety analyses. At least 34 subjects/treatment group received all treatment and had complete RVNA results, thus were included in the primary endpoint analysis. Mean RVNAs were approximately ten-fold higher in SYN023 recipients compared to HyperRab recipients until Day 14. From Day 14 onwards, mean RVNA was lower in SYN023 recipients, but remained above the RVNA level widely considered adequate (≥0.5 IU/mL) through Day 112 (study end). The point estimate of the cumulative RVNA (83.22% SYN023/HyperRab), but not the lower CI bound (90% CI: 66.06%, 104.83%), fell within the protocol-defined similarity margin. Each RIG + vaccine regimen appeared safe with mostly mild AEs and no serious or severe related events observed. Except injection site pain (22% HyperRab recipients vs. 6% SYN023 recipients), treatment-related AEs incidences were similar between RIGs. Anti-SYN023 antibodies were observed but had no apparent effects on PK or safety.
CONCLUSIONS:
SYN023 administered with commercially available vaccines provides adequate antibody coverage beginning earlier than other commercially available RIGs with an acceptable safety profile. Some suppression of vaccine response occurred, but RVNA levels ≥ 0.5 IU/mL were maintained throughout the relevant period.
REGISTRATION:
ClinicalTrials.gov #NCT02956746.
FUNDING:
Synermore biologics.
2021-07-01Clinical pharmacology in drug development
Safety, Pharmacokinetics, and Neutralizing Activity of SYN023, a Mixture of Two Novel Antirabies Monoclonal Antibodies Intended for Use in Postrabies Exposure Prophylaxis
Article
作者: McClain, J. Bruce ; Chuang, Ariel ; Tsao, Eric ; Moore, Susan M.
Abstract:
SYN023 is a mixture of 2 humanized monoclonal antirabies antibodies (CTB011, CTB012). Two first‐in‐human studies evaluated ascending intramuscular (IM) injected doses (Study SYN023‐001; N = 15) and IM vs subcutaneous (SC) administration (Study SYN023‐003; N = 35) in healthy adults. In both studies, end points were safety, pharmacokinetics (PK), pharmacodynamics/rabies virus neutralizing activity (RVNA), and immunogenicity (anti‐SYN023 antibodies). Adverse events were mild and infrequent at all doses tested by IM injection (0.3 mg/kg, 1.0 mg/kg, 2.0 mg/kg), or by SC injection (0.3 mg/kg). There were no apparent trends in adverse event frequency or nature with increased dose or with administration route. Serum PK of SYN023 component antibodies appeared comparable to each other at each dose tested and when administered IM versus SC with serum exposure doubling over the second week after administration. At the lowest dose tested (0.3 mg/kg) by either IM or SC injection, RVNA levels exceeded the concentration generally accepted as protective against rabies (≥0.5 IU/mL) by day 1 after administration. Supra‐inhibitory levels persisted >42 days. RVNA increased with higher doses. Anti‐CTB011 and anti‐CTB012 antibodies occurred with no apparent effect on PK or safety. These data support the potential use of SYN023 in antirabies postexposure prophylaxis.
2020-12-01Antiviral research2区 · 医学
Safety, pharmacokinetics and pharmacodynamics of SYN023 alone or in combination with a rabies vaccine: An open, parallel, single dose, phase 1 bridging study in healthy Chinese subjects
2区 · 医学
Article
作者: Liu, Jingrui ; Ding, Yanhua ; Li, Xiaojiao ; Li, Cuiyun ; Tsao, Eric ; Zhu, Xiaoxue ; Zhang, Hong ; Liu, Ming ; Hu, Yue ; Wu, Min
BACKGROUND:
SYN023, a mixture of two anti-rabies humanized monoclonal antibodies (mAbs), namely, CTB011 and CTB012, has been developed as a safe and cost-effective alternative to RIG in the use of postexposure prophylaxis (PEP) after rabies exposure.
METHODS:
This phase I bridging study was designed to compare the pharmacokinetics (PK) of SYN023 (0.3 mg/kg) alone (cohort A, n = 8) or in combination with a rabies vaccine (cohort B, n = 24) in healthy Chinese subjects with those in American subjects to guide the design of further clinical trials. Their safety was assessed for the development of adverse events (AEs) by laboratory examinations. The levels of serum CTB011, CTB012 and anti-drug antibodies (ADAs) were measured longitudinally for 85 days. Serum rabies virus neutralizing antibody (RVNA) levels were measured as a pharmacodynamic (PD) surrogate.
RESULTS:
Some subjects with injectable SYN023 at 0.3 mg/kg developed temporary AEs and adverse drug reactions (ADRs) of Grade 1 or 2, particularly in cohort B, probably due to vaccine coadministration. SYN023 injection displayed a typical and reliable PK, similar to that of human IgGs. Following injection with SYN023, Chinese subjects had slower absorption with higher exposures for CTB011 but lower exposures for CTB012 than American subjects. The SYN023 recipients achieved protective levels of RVNA (≥0.5 IU/mL) on day 3 post injection. A few subjects developed temporary ADA, which did not affect the safety and PK/PD of SYN023 in Chinese subjects.
CONCLUSION:
SYN023 at 0.3 mg/kg is relatively saf e and effective and can be selected for further clinical trials in Chinese subjects. The clinical trial registration number is CTR20190281. http://www.chinadrugtrials.org.cn/eap/clinicaltrials.searchlist?a=a®_no=CTR20190281.
100 项与 泽美洛韦/玛佐瑞韦单抗 相关的药物交易
登录后查看更多信息
研发状态
10 条最早获批的记录, 后查看更多信息
登录
| 适应症 | 国家/地区 | 公司 | 日期 |
|---|---|---|---|
| 狂犬病 | 中国 | 2024-06-04 |
登录后查看更多信息
临床结果
临床结果
适应症
分期
评价
查看全部结果
NEWS 人工标引  | N/A | 1,448 | 克瑞毕±人狂犬病免疫球蛋白（HRIG） | 蓋淵築窪築膚廠鹹淵艱(繭選遞觸憲夢窪壓構遞) = 基于6项临床试验的研究结果，克瑞毕®在狂犬病病毒暴露者及健康受试者中无论是单独使用还是与狂犬病疫苗联用，皆具有良好的安全性。结果显示，克瑞毕®组受试者的不良反应发生率要低于HRIG组，且克瑞毕®组内没有因不良反应导致退出的受试者，常见的不良反应多为注射部位肿胀及疼痛，不良反应发生率显著低于HRIG对照组。 簾鏇觸製網廠壓範糧製 (積顧遞築網齋網鹽願膚 ) | 积极 | 2023-10-20 | |
临床3期 | 1,000 | Rabies Vaccine+SYN023 | 憲艱廠網憲淵齋網製觸(艱鹹鏇鑰蓋憲襯繭鬱網) = 餘餘齋淵窪襯鹹衊鏇構 憲鏇淵憲遞製憲壓範鏇 (淵顧鏇憲膚廠襯膚艱繭, 鏇範夢壓艱鑰範鹽觸壓 ~ 遞顧獵鏇糧網繭選選築) 更多 | - | 2023-04-21 | ||
临床2期 | 164 | 願繭鑰齋窪網繭願簾範(鹹願構遞構糧獵鹽構獵) = 鏇繭鹽衊醖鑰構獵艱構 淵糧鑰遞鏇壓範壓糧簾 (範範齋壓觸壓鹽選製鑰 ) 更多 | 积极 | 2021-09-24 | |||
rabies vaccination+HyperRab | 選觸鏇積網遞襯觸簾蓋(鏇窪網鹹壓衊糧獵憲齋) = 艱遞積鑰鬱醖廠糧選鏇 夢蓋壓夢餘製憲艱願範 (淵鑰獵醖艱願繭襯壓壓 ) | ||||||
临床1/2期 | 164 | 夢鬱窪餘簾衊窪築醖夢(繭構膚獵繭範製製鏇憲) = 願網願鑰構願艱憲遞齋 膚夢襯簾鹽範築簾鬱壓 (鹹選醖窪衊壓簾獵蓋簾, 選構遞選遞構觸艱壓願 ~ 構製範鏇淵簾艱獵膚餘) 更多 | - | 2019-02-27 | |||
Imovax+HyperRAB ST (human rabies immune globulin) (Imovax, Human Rabies Immune Globulin) | 夢鬱窪餘簾衊窪築醖夢(繭構膚獵繭範製製鏇憲) = 襯獵鑰膚願膚夢觸顧顧 膚夢襯簾鹽範築簾鬱壓 (鹹選醖窪衊壓簾獵蓋簾, 構網構願夢簾淵淵餘齋 ~ 糧醖窪鹹糧鏇顧製膚網) 更多 |
登录后查看更多信息
转化医学
使用我们的转化医学数据加速您的研究。
登录
或
药物交易
使用我们的药物交易数据加速您的研究。
登录
或
核心专利
使用我们的核心专利数据促进您的研究。
登录
或
临床分析
紧跟全球注册中心的最新临床试验。
登录
或
批准
利用最新的监管批准信息加速您的研究。
登录
或
特殊审评
只需点击几下即可了解关键药物信息。
登录
或
立即开始免费试用!
智慧芽新药情报库是智慧芽专为生命科学人士构建的基于AI的创新药情报平台，助您全方位提升您的研发与决策效率。
立即开始数据试用!
智慧芽新药库数据也通过智慧芽数据服务平台，以API或者数据包形式对外开放，助您更加充分利用智慧芽新药情报信息。
生物序列数据库
生物药研发创新
免费使用
化学结构数据库
小分子化药研发创新
免费使用