(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-

CTR20243298 / Not yet recruitingPhase 1/2

ART001注射液治疗转甲状腺素蛋白淀粉样变性心肌病的多中心、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 cardiomyopathy

1、主要目的：评估ART001注射液在转甲状腺素蛋白淀粉样变性心肌病（ATTR-CM）受试者中的安全性和耐受性； 2、次要目的：评估ART001注射液在ATTR-CM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]

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.

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

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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

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Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


ChiCTR2400081216 (NEWS) Manual	Not Applicable	Amyloidosis, Hereditary, Transthyretin-Related	10	ART001	hqpssuxqgc(qgeubngpjm) = 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。 cveysjyliy (pgllqqlkkr ) View more	Positive	27 May 2024

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