Pharmacokinetics and Pharmacodynamics Study

Launched by QILU PHARMACEUTICAL CO., LTD. · Jul 10, 2025

Keywords

ClinConnect Summary

This clinical trial is studying how the body processes and responds to two different versions of a medicine called QLC7401, which is used to treat people with high levels of “bad” cholesterol (LDL-C) or combined high cholesterol and fats in the blood. The main goal is to see if changing the location where the medicine is made affects how it works in the body. This study is in an early phase (Phase 1) and is not yet open for participants.

Adults between 18 and 65 years old with certain cholesterol levels may be eligible to join. To qualify, participants should have a body weight and cholesterol levels within specific ranges, and should not have diabetes, serious mental health issues, or certain kidney or liver problems. People who have taken prescription drugs recently may also not be eligible. If you participate, you can expect careful monitoring of how your body handles the medicine, which helps researchers understand its safety and effects. This study focuses on healthy volunteers with controlled cholesterol, so it’s important to meet all the criteria to ensure accurate and safe results.

Gender

ALL

Eligibility criteria

• 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.