1. Primary objective: To evaluate the safety and tolerability of ART001 injection in subjects with transthyretin amyloid cardiomyopathy (ATTR-CM); 2. Secondary objective: To evaluate the pharmacokinetics (PK), pharmacodynamics (PD), immunogenicity and efficacy of ART001 injection in subjects with ATTR-CM.

Start Date-

Sponsor / Collaborator

Accuredit Therapeutics (Suzhou) Co., Ltd.

CTR20243089 / Not yet recruitingPhase 1/2

ART001注射液治疗转甲状腺素蛋白淀粉样变性多发性神经病的多中心、开放、单臂I/IIa期临床研究

[Translation] A multicenter, open, single-arm phase I/IIa clinical study of ART001 injection in the treatment of transthyretin amyloid polyneuropathy

主要目的：评估ART001注射液在转甲状腺素蛋白淀粉样变性多发性神经病（ATTR-PN）受试者中的安全性和耐受性；次要目的：评估ART001注射液在ATTR-PN受试者中的药代动力学（PK）、药效动力学（PD）、免疫原性和疗效。

[Translation]

Primary objective: To evaluate the safety and tolerability of ART001 injection in subjects with transthyretin amyloidosis polyneuropathy (ATTR-PN); Secondary objective: To evaluate the pharmacokinetics (PK), pharmacodynamics (PD), immunogenicity and efficacy of ART001 injection in subjects with ATTR-PN.

Start Date-

Sponsor / Collaborator

Accuredit Therapeutics (Suzhou) Co., Ltd.

ChiCTR2400081216 / RecruitingEarly Phase 1

(Open-Label, Single Ascending Dose) Study to Evaluate Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of ART001 in Patients with Transthyretin Amyloidosis

Start Date30 Jul 2023

Sponsor / Collaborator-

100 Clinical Results associated with ART-001(Accuredit)

100 Translational Medicine associated with ART-001(Accuredit)

100 Patents (Medical) associated with ART-001(Accuredit)

100 Deals associated with ART-001(Accuredit)

R&D Status

10 top R&D records.

to view more data

Indication	Highest Phase	Country/Location	Organization	Date
Amyloid Neuropathies	Phase 2	CN	Accuredit Therapeutics (Suzhou) Co., Ltd.	30 Aug 2024
Transthyretin Amyloid Cardiomyopathy	Phase 2	CN	Accuredit Therapeutics (Suzhou) Co., Ltd.	30 Aug 2024
Transthyretin cardiac amyloidosis	Phase 1	CN	Accuredit Therapeutics (Suzhou) Co., Ltd.	20 Oct 2023
Transthyretin-mediated amyloidosis	IND Approval	CN	Accuredit Therapeutics (Suzhou) Co., Ltd.	22 Jul 2024

Clinical Result

Indication

Phase

Evaluation

View All Results

Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


ChiCTR2400081216 (NEWS) Manual	Not Applicable	Amyloidosis, Hereditary, Transthyretin-Related	10	ART001	fpslalltar(wyisfyupxp) = 给药后4周，高剂量组受试者外周TTR蛋白较基线即可平均下降90%以上。 hjwdzgiout (lvhmhyshnp ) View more	Positive	27 May 2024

Translational Medicine

Boost your research with our translational medicine data.

view full example data

Deal

Boost your decision using our deal data.

view full example data

Core Patent

Boost your research with our Core Patent data.

view full example data

Clinical Trial

Identify the latest clinical trials across global registries.

view full example data

Approval

Accelerate your research with the latest regulatory approval information.

view full example data

Regulation

Understand key drug designations in just a few clicks with Synapse.

view full example data

Chat with Hiro

Get started for free today!

Accelerate Strategic R&D decision making with Synapse, PatSnap’s AI-powered Connected Innovation Intelligence Platform Built for Life Sciences Professionals.

Start your data trial now!

Synapse data is also accessible to external entities via APIs or data packages. Empower better decisions with the latest in pharmaceutical intelligence.

Bio

Bio Sequences Search & Analysis

Chemical

Chemical Structures Search & Analysis

ART-001(Accuredit)

Overview

Basic Info

Related

R&D Status

Clinical Result

Translational Medicine

Deal

Core Patent

Clinical Trial

Approval

Regulation