Not Yet RecruitingPhase 1

Pharmacokinetics and Pharmacodynamics Study

China48 participantsStarted 2025-07

Plain-language summary

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.

Who can participate

Age range

18 Years – 65 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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.

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Cmax

Timeframe: 0.25, 0.5, 1, 2, 4, 6, 8, 12, 24, 48 hours post dose

AUC

Timeframe: 0.25, 0.5, 1, 2, 4, 6, 8, 12, 24, 48 hours post dose

Tmax

Timeframe: 0.25, 0.5, 1, 2, 4, 6, 8, 12, 24, 48 hours post dose

t1/2

Timeframe: 0.25, 0.5, 1, 2, 4, 6, 8, 12, 24, 48 hours post dose

CL/F

Timeframe: 0.25, 0.5, 1, 2, 4, 6, 8, 12, 24, 48 hours post dose

VZ/F

Timeframe: 0.25, 0.5, 1, 2, 4, 6, 8, 12, 24, 48 hours post dose

Trial details

NCT IDNCT07074236

SponsorQilu Pharmaceutical Co., Ltd.

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2026-01

Contact for this trial

Yu Cao, doctorate

0532-82911767 Caoyu1767@126.com

View on ClinicalTrials.gov More Primary Hypercholesterolemia or Combined Hyperlipidemia Characterized by Elevated LDL-C trials

Who can participate

Age range

18 Years – 65 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

What they're measuring

Cmax

Timeframe: 0.25, 0.5, 1, 2, 4, 6, 8, 12, 24, 48 hours post dose

AUC

Timeframe: 0.25, 0.5, 1, 2, 4, 6, 8, 12, 24, 48 hours post dose

Tmax

Timeframe: 0.25, 0.5, 1, 2, 4, 6, 8, 12, 24, 48 hours post dose

t1/2

Timeframe: 0.25, 0.5, 1, 2, 4, 6, 8, 12, 24, 48 hours post dose

CL/F

Timeframe: 0.25, 0.5, 1, 2, 4, 6, 8, 12, 24, 48 hours post dose

VZ/F

Timeframe: 0.25, 0.5, 1, 2, 4, 6, 8, 12, 24, 48 hours post dose