DS-2325a(DS-2325a) - 药物靶点：KLK5_在研适应症：Netherton综合征_专利_临床

概要

基本信息

药物类型

基因疗法

别名

a fusion protein comprised of genetically engineered human serine peptidase inhibitor KAZAL Type 2 (SPINK2) and human immunoglobulin G (IgG) 1 Fc.

+ [1]

靶点

KLK5

作用机制

KLK5抑制剂(kallikrein related peptidase 5 inhibitors)、基因转移

治疗领域

遗传病与畸形皮肤和肌肉骨骼疾病其他疾病

在研适应症

Netherton综合征

非在研适应症-

原研机构

Daiichi Sankyo, Inc.

在研机构

Daiichi Sankyo, Inc.

Daiichi Sankyo Co., Ltd.

非在研机构-

最高研发阶段临床1/2期

首次获批日期-

最高研发阶段(中国)-

特殊审评孤儿药 (美国)

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关联

3

项与 DS-2325a 相关的临床试验

NCT05979831 / Active, not recruiting临床1/2期

A Phase 1b/2, Double-Blind, Placebo-Controlled, Randomized, Parallel-Arm Study to Explore Safety, Pharmacokinetics, and Early Clinical Signal of Efficacy of DS-2325a in Patients With Netherton Syndrome

Netherton Syndrome (NS) is a severe rare disease characterized by generalized scaling, erythema, and epidermal barrier defects. This study assessed the safety, pharmacokinetics (PK), and efficacy of DS-2325a in patients with NS.

开始日期2023-09-28

申办/合作机构

Daiichi Sankyo Co., Ltd.

NCT05583669 / Completed临床1期

A Phase 1, Subject- and Investigator-Blinded, Sponsor-Unblinded, Placebo-Controlled, Randomized, Sequential Cohort Study to Assess the Safety and Pharmacokinetics of Multiple Ascending Subcutaneous Doses of DS-2325a in Healthy Subjects

Netherton syndrome (NS) is a rare autosomal recessive disease and no systemic treatment or standard of care currently exists for patients with NS. DS-2325a, a specific and potent inhibitor of kallikrein 5, is expected to treat NS by replacing a defective gene.

开始日期2022-11-08

申办/合作机构

Daiichi Sankyo, Inc.

NCT05388903 / Completed临床1期

A Phase 1, Subjects- and Investigator-Blinded, Sponsor-Unblinded, Placebo-Controlled, Randomized, Sequential Cohort Study to Assess the Safety and Pharmacokinetics of Single Ascending Subcutaneous and Intravenous Doses of DS-2325a in Healthy Subjects

Netherton syndrome (NS) is a rare autosomal recessive disease and no systemic treatment or standard of care currently exists for patients with NS. DS-2325a, a specific and potent inhibitor of kallikrein 5, is expected to treat NS by replacing a defective gene.

开始日期2022-06-20

申办/合作机构

Daiichi Sankyo, Inc.

100 项与 DS-2325a 相关的临床结果

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100 项与 DS-2325a 相关的转化医学

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100 项与 DS-2325a 相关的专利（医药）

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100 项与 DS-2325a 相关的药物交易

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