NCT07074236Not yet recruitingPhase 1
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
Source: ClinicalTrials.gov · Last updated 24 Jul 2025 · Not updated for over 12 months - ask the site whether it is still open
Brief summary (registry, in English)
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.
- Status (registry)
- Not yet recruiting
- Phase (registry)
- Phase 1
- Study type
- Interventional
- Enrollment
- 48 (estimated)
- First submitted
- 10 Jul 2025
- Start date
- 1 Jul 2025
- Primary completion date
- 31 Jan 2026
- Lead sponsor
- Qilu Pharmaceutical Co., Ltd.
- Diseases
- Familial hypercholesterolaemia
- NCT number
- NCT07074236
What you commit to
- Study type: Interventional · Phase 1
- Planned participants: 48
- From 1 Jul 2025 to the primary completion date, 31 Jan 2026
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Subjects administered prescription drugs 14 days before the first drug administration.
Other illness
- Subjects with confirmed diabetes.
- Subjects with severe active psychiatric illness or disorder.
Lab values
- 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.
Who the study is looking for
- 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).
Age in the registry: 18 years to 65 years · Sex: All · Accepts healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| The Affiliated Hospital of Qingdao University Coordinator of this site? Confirm its status | Qingdao | China | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.