[Translation] A Phase Ib/IIa clinical trial evaluating the safety, tolerability, pharmacokinetic characteristics, and efficacy of YKYY015 injection in participants with elevated low-density lipoprotein cholesterol (LDL-C)
Ib期:
主要目的:评价YKYY015注射液皮下注射多次给药在低密度脂蛋白胆固醇(LDL-C)升高参与者中的安全性和耐受性。
次要目的:评价YKYY015注射液皮下注射多次给药的药代动力学(PK)特征;评价YKYY015注射液在低密度脂蛋白胆固醇(LDL-C)升高参与者中的药效学特征;评价YKYY015注射液在低密度脂蛋白胆固醇(LDL-C)升高参与者中的免疫原性。评价YKYY015注射液在他汀类药物治疗下低密度脂蛋白胆固醇(LDL-C)升高参与者中的疗效。
IIa期:
主要目的:评价YKYY015注射液在他汀类药物治疗下低密度脂蛋白胆固醇(LDL-C)升高参与者中的疗效。
次要目的:评价YKYY015注射液在他汀类药物治疗下的低密度脂蛋白胆固醇(LDL-C)升高参与者中的安全性;评价YKYY015注射液在他汀类药物治疗下的低密度脂蛋白胆固醇(LDL-C)升高参与者中的免疫原性。
[Translation] Phase Ib:
Primary Objective: To evaluate the safety and tolerability of YKYY015 injection after multiple subcutaneous administration in participants with elevated low-density lipoprotein cholesterol (LDL-C).
Secondary Objectives: To evaluate the pharmacokinetic (PK) characteristics of YKYY015 injection after multiple subcutaneous administration; to evaluate the pharmacodynamic characteristics of YKYY015 injection in participants with elevated low-density lipoprotein cholesterol (LDL-C); and to evaluate the immunogenicity of YKYY015 injection in participants with elevated low-density lipoprotein cholesterol (LDL-C). To evaluate the efficacy of YKYY015 injection in participants with elevated low-density lipoprotein cholesterol (LDL-C) on statin therapy.
Phase IIa:
Primary Objective: To evaluate the efficacy of YKYY015 injection in participants with elevated low-density lipoprotein cholesterol (LDL-C) on statin therapy.
Secondary objectives: To evaluate the safety of YKYY015 injection in participants with elevated low-density lipoprotein cholesterol (LDL-C) under statin treatment; to evaluate the immunogenicity of YKYY015 injection in participants with elevated low-density lipoprotein cholesterol (LDL-C) under statin treatment.