[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.