A Phase IIb, Randomized, Double-blind, Multicenter, Placebo-controlled Study Evaluating the Efficacy and Safety of CT-P27 in Subjects with Acute Uncomplicated Influenza A Infection

开始日期2016-12-09

申办/合作机构

Celltrion, Inc.

NCT03511066 / Terminated临床2期

A Phase IIb, Randomized, Double-blind, Multicenter, Placebo-controlled Study Evaluating the Efficacy and Safety of CT-P27 in Subjects With Acute Uncomplicated Influenza A Infection

This study is a Phase IIb, Randomized, Double-blind, Multicenter, Placebo-controlled study evaluating the efficacy and safety of CT-P27 in subjects with acute uncomplicated influenza A infection.

开始日期2016-12-09

申办/合作机构

Celltrion, Inc.

NCT02071914 / Completed临床2期

A Randomised, Double-Blind, Placebo-Controlled, Single-Centre, Phase IIa Study in Healthy Volunteers to Evaluate the Efficacy and Safety of CT-P27 in an Influenza Challenge Model

This study is to evaluate the efficacy of CT-P27 measured by quantitative PCR viral load from nasopharyngeal mucosa, compared to placebo.

开始日期2014-02-15

申办/合作机构

Celltrion, Inc.

100 项与 Navivumab 相关的临床结果

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100 项与 Navivumab 相关的转化医学

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100 项与 Navivumab 相关的专利（医药）

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项与 Navivumab 相关的文献（医药）

PLOS ONE3区 · 综合性期刊

Broader neutralization of CT-P27 against influenza A subtypes by combining two human monoclonal antibodies

3区 · 综合性期刊

ArticleOA

作者: Ryu, Dong-Kyun ; Shin, JiYoung ; Lee, Soo-Young ; Choi, Jung-Ah ; Yi, Kye Sook ; Lee, Sena ; Lee, Eun Beom ; Son, Dain ; Chae, Ji-Sang ; Song, Manki ; Yang, Eunji ; Kim, Pankyeom ; Im, Bok-Hyeon ; Park, Hayan ; Lee, HyunJoo

There are several broadly neutralizing monoclonal antibodies that neutralize influenza viruses with different mechanisms from traditional polyclonal antibodies induced by vaccination. CT149, which is one of the broadly neutralizing antibodies, was also previously reported to neutralize group 2 and some of group 1 influenza viruses (13 out of 13 tested group 2 viruses and 5 out of 11 group 1 viruses). In this study, we developed another antibody with the aim of compensating partial coverage of CT149 against group 1 influenza viruses. CT120 was screened among different antibody candidates and mixed with CT149. Importantly, although the binding sites of CT120 and CT149 are close to each other, the two antibodies do not interfere. The mixture of CT120 and CT149, which we named as CT-P27, showed broad efficacy by neutralizing 37 viruses from 11 different subtypes, of both group 1 and 2 influenza A viruses. Moreover, CT-P27 showed in vivo therapeutic efficacy, long prophylactic potency, and synergistic effect with oseltamivir in influenza virus-challenged mouse models. Our findings provide a novel therapeutic opportunity for more efficient treatment of influenza.

100 项与 Navivumab 相关的药物交易

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研发状态

10 条进展最快的记录,

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适应症	最高研发状态	国家/地区	公司	日期
甲型流感病毒感染	临床2期	-	Centers for Disease Control & Prevention	-
甲型流感病毒感染	临床2期	-	Yonsei University Health System	-

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临床结果

适应症

分期

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研究	分期	人群特征	评价人数	分组	结果	评价	发布日期


NCT03511066 (CTgov)	临床2期	甲型流感病毒感染	228	CT-P27 90 mg/kg (CT-P27 90 mg/kg)	網鹽膚蓋窪顧窪獵範襯(鹽繭蓋顧窪範鏇構鑰鏇) = 範觸衊製憲廠窪淵觸顧鬱願蓋選淵蓋壓獵簾鏇 (襯製構膚衊襯鏇壓顧壓, 顧選膚膚製壓廠獵鏇壓 ~ 鹽壓構壓壓願憲廠鏇蓋) 更多	-	2022-10-31
				CT-P27 45 mg/kg (CT-P27 45mg/kg)	網鹽膚蓋窪顧窪獵範襯(鹽繭蓋顧窪範鏇構鑰鏇) = 鹹築願鏇鏇鬱顧憲壓膚鬱願蓋選淵蓋壓獵簾鏇 (襯製構膚衊襯鏇壓顧壓, 襯淵鑰鏇壓膚夢蓋鏇網 ~ 衊網齋願衊醖簾鏇醖觸) 更多
NCT02071914 (CTgov)	临床2期	甲型流感病毒感染	81	CT-P27 (CT-P27 10mg/kg)	鑰蓋蓋鏇糧憲鏇鬱齋選(齋淵範獵獵夢顧蓋鬱憲) = 製築遞獵顧積遞廠願網鹽鬱淵壓淵遞襯廠憲顧 (廠積艱獵淵鑰鬱鏇膚醖, 壓鹽齋糧顧築憲餘齋窪 ~ 齋壓糧築齋醖網壓糧遞) 更多	-	2020-03-16
				CT-P27 (CT-P27 20mg/kg)	鑰蓋蓋鏇糧憲鏇鬱齋選(齋淵範獵獵夢顧蓋鬱憲) = 淵繭蓋憲膚網築齋糧選鹽鬱淵壓淵遞襯廠憲顧 (廠積艱獵淵鑰鬱鏇膚醖, 網簾遞鬱鬱網窪繭積廠 ~ 製憲願築窪鬱簾蓋網窪) 更多