[Translation] A randomized, double-blind, placebo-controlled, single-ascending dose Phase I clinical study to evaluate the safety, tolerability, pharmacokinetics and pharmacodynamics of DNV001 injection in subjects with normal or elevated low-density lipoprotein cholesterol
主要目的:
1. 评价受试者单次DNV001注射液皮下给药后的安全性、耐受性。
次要目的:
2. 评价受试者单次DNV001注射液皮下给药后的药代动力学(PK)
特征;
3. 评价受试者单次DNV001注射液皮下给药后对血清LDL-C水平的
药效学影响;
4. 评价受试者单次DNV001注射液皮下给药后对血浆PCSK9水平的
药效学影响;
5. 评价受试者单次DNV001注射液皮下给药后对血清其他血脂参数
的药效学影响;
6. 评价受试者单次DNV001注射液皮下给药后的免疫原性。
探索性目的:
7. 受试者单次DNV001注射液皮下给药对QT间期的影响。
[Translation] Main objectives:
1. To evaluate the safety and tolerability of a single subcutaneous administration of DNV001 injection to subjects.
Secondary objectives:
2. To evaluate the pharmacokinetic (PK) characteristics of a single subcutaneous administration of DNV001 injection to subjects;
3. To evaluate the pharmacodynamic effect of a single subcutaneous administration of DNV001 injection on serum LDL-C levels;
4. To evaluate the pharmacodynamic effect of a single subcutaneous administration of DNV001 injection on plasma PCSK9 levels;
5. To evaluate the pharmacodynamic effect of a single subcutaneous administration of DNV001 injection on other serum lipid parameters;
6. To evaluate the immunogenicity of a single subcutaneous administration of DNV001 injection to subjects.
Exploratory objectives:
7. The effect of a single subcutaneous administration of DNV001 injection on the QT interval of subjects.