Pharmacokinetics and Pharmacodynamics Study

A Randomized, Open-label, Single-center, Parallel Study in Subjects With Normal or Elevated Low-density Lipoprotein Cholesterol Level to Compare the Pharmacokinetics and Pharmacodynamics of the Two Formulations of QLC7401 Injection

The purpose of this study is to compare the pharmacokinetics and pharmacodynamics behavior of the two formulation of QLC7401 injection to further evaluate the effect of the production site change.

Inclusion Criteria:

• Males and females who are 18 to 65 years of age.
• BMI is within the range of 18~28 kg/m2 (including the boundary value).
• LDL-C is within the range of 1.8 mmol/L (70 mg/dl) and 4.1 mmol/L (158 mg/dl) (including the lower boundary value). TG is less than or equal to 4.5 mmol/L (400 mg/dl).
• TC is less than 6.2 mmol/L (239 mg/dl).

Exclusion Criteria:

• Subjects with confirmed diabetes.
• Subjects with severe active psychiatric illness or disorder.
• eGFR is less than 90 ml/min.
• AST is equal to or above the 2 fold of upper limit of normal value or TBIL is equal to or above the 1.5 fold of upper limit of normal value.
• Subjects administered prescription drugs 14 days before the first drug administration.