Compares two versions of an injection for high cholesterol
Compares how two formulations of QLC7401 injection behave in adults with high LDL cholesterol.
Plain-language title generated from the registry record
Registry title: Pharmacokinetics and Pharmacodynamics Study
Key facts
- Where
- Qingdao, ChinaSee the site
- Phase
- Phase 1
Could this be for you?
Answer for yourself. This is not a decision: only the study team can say whether you can take part.
- Are you between 18 and 65 years old?
Source: NCT07074236, who can take part
Where in China
- The Affiliated Hospital of Qingdao UniversityQingdao, ChinaNo longer taking part
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- Qilu Pharmaceutical Co., Ltd.
- Trial code
- NCT07074236
- Record updated
- 24 July 2025
- Original description
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.Read full original descriptionShow less
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: 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: Subjects administered prescription drugs 14 days before the first drug administration; 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.