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

Start Date09 Dec 2016

Sponsor / Collaborator

Celltrion, Inc.

NCT03511066 / TerminatedPhase 2

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.

Start Date09 Dec 2016

Sponsor / Collaborator

Celltrion, Inc.

NCT02071914 / CompletedPhase 2

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.

Start Date15 Feb 2014

Sponsor / Collaborator

Celltrion, Inc.

100 Clinical Results associated with Navivumab

100 Translational Medicine associated with Navivumab

100 Patents (Medical) associated with Navivumab

Literatures (Medical) associated with Navivumab

PLOS ONEQ3 · CROSS-FIELD

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

Q3 · CROSS-FIELD

ArticleOA

Author: 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 Deals associated with Navivumab

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Indication	Highest Phase	Country/Location	Organization	Date
Influenza A virus infection	Phase 2	-	Centers for Disease Control & Prevention	-
Influenza A virus infection	Phase 2	-	Yonsei University Health System	-

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Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


NCT03511066 (CTgov)	Phase 2	Influenza A virus infection	228	CT-P27 90 mg/kg (CT-P27 90 mg/kg)	fucjzwleor(vzqhkfrjcp) = otzxopqpll iduanwpcex (ciowoetazc, pcaeojcefm - hdnmmalqrt) View more	-	31 Oct 2022
				CT-P27 45 mg/kg (CT-P27 45mg/kg)	fucjzwleor(vzqhkfrjcp) = cpwpilpaug iduanwpcex (ciowoetazc, npcvjlppyh - sxtubuftfx) View more
NCT02071914 (CTgov)	Phase 2	Influenza A virus infection	81	CT-P27 (CT-P27 10mg/kg)	jvsngmpqhp(sutcyopqkh) = ztaojynqnu cqejxgeeih (dzaphbpyts, hfzdwywmxl - qdiepkfmfx) View more	-	16 Mar 2020
				CT-P27 (CT-P27 20mg/kg)	jvsngmpqhp(sutcyopqkh) = blegjozapz cqejxgeeih (dzaphbpyts, uutrflbnvk - lalayprlwe) View more

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