依那西普生物类似药（mAbxience SA）(MB-04) - 药物靶点：LTα x TNF-α_在研适应症：类风湿关节炎，自身免疫性疾病_专利_临床

概要

基本信息

药物类型

生物类似药、融合蛋白

别名

Etanercept Biosimilar (mAbxience SA)

靶点

LTα x TNF-α

作用机制

LTα抑制剂(肿瘤坏死因子β抑制剂)、TNF-α抑制剂(肿瘤坏死因子α抑制剂)

治疗领域

免疫系统疾病皮肤和肌肉骨骼疾病

在研适应症

类风湿关节炎自身免疫性疾病

非在研适应症-

原研机构

mAbxience SA

在研机构

mAbxience Research SLmAbxience SA

非在研机构-

最高研发阶段临床3期

首次获批日期-

最高研发阶段(中国)-

特殊审评-

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序列信息

Sequence Code 38320

当前序列信息引自: *****

关联

3

项与依那西普生物类似药（mAbxience SA）相关的临床试验

CTIS2024-510826-16-00 / Recruiting

A Prospective, Randomized, Double-blind, Parallel-group Study to Compare the Efficacy, Safety, Pharmacokinetics, and Immunogenicity of MB04 and EU-sourced Enbrel® in Patients with Moderate to Severe Rheumatoid Arthritis. - MB04-C-01-23

开始日期2024-10-02

申办/合作机构

mAbxience Research SL

NCT06596772 / Recruiting临床3期

A Prospective, Randomized, Double-blind, Parallel-group Study to Compare the Efficacy, Safety, Pharmacokinetics and Immunogenicity of MB04 and EU-sourced Enbrel® in Patients with Moderate to Severe Rheumatoid Arthritis

A study to compare efficacy, pharmacokinetics, safety and immunogenicity of MB04 [proposed etanercept biosimilar] to Enbrel® [EU-sourced] in rheumatoid arthritis

开始日期2024-09-11

申办/合作机构

mAbxience Research SL

NCT06392074 / Active, not recruiting临床1期

A Randomized, Double-blind, Three-part, Two-period, Two-sequence, Single-dose, Cross-over Study to Compare the Pharmacokinetics (PK), Safety and Immunogenicity Profile of MB04 (proposed Etanercept Biosimilar), EU-sourced Enbrel® and US Licensed Enbrel® in Healthy Male Volunteers

This is a randomized, double-blind, three-part, two-sequence per part, two-period, single-dose, cross-over study in healthy male volunteers to compare the PK, safety, and immunogenicity of MB04 and EU /US Enbrel®.
During the course of the study, the similarity in pharmacokinetics will be assessed by sampling the levels of drug in the blood, and by comparing these levels among the different administration arms. Safety, tolerability, and immunologic response to the administered drugs will also be evaluated throughout.

开始日期2024-03-07

申办/合作机构

mAbxience Research SL

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