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NCT Number: NCT07074236

Pharmacokinetics and Pharmacodynamics Study

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.

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Key information

Conditions

Primary Hypercholesterolemia or Combined Hyperlipidemia Characterized by Elevated LDL-C

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

The Affiliated Hospital of Qingdao University.

Qingdao, China

Location contact

Yu Cao

CONTACT

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

QLC7401 injection

Drug

QLC7401 injection is a small interfering RNA (siRNA) directed to PCSK9 (proprotein convertase subtilisin kexin type 9) mRNA to inhibit the translation of PCSK9 and reduce expression of PCSK9 protein further to lower the level of LDL-C. QLC7401 injection was introduced by Qilu Pharmaceutical Co., Ltd. from Suzhou Ruibo Biotechnology Co., Ltd. QLC7401 injection was produced by Qilu Pharmaceutical Co., Ltd.

RBD7022 injection

Drug

RBD7022 injection is a small interfering RNA (siRNA) directed to PCSK9 (proprotein convertase subtilisin kexin type 9) mRNA to inhibit the translation of PCSK9 and reduce expression of PCSK9 protein further to lower the level of LDL-C. RBD7022 injection was produced by Suzhou Ruibo Biotechnology Co., Ltd.

Primary outcomes

  1. Cmax

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

    Maximum plasma concentration of QLC7401 and active metabolites.

  2. AUC

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

    Area under the concentration-time curve of QLC7401 and active metabolites.

  3. Tmax

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

    Time of maximum observed concentration of QLC7401 and active metabolites..

  4. t1/2

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

    Terminal elimination half-life of QLC7401 and active metabolites.

  5. CL/F

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

    Apparent total clearance of the drug from plasma after oral administration of QLC7401 and active metabolites.

  6. VZ/F

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

    Apparent volume of distribution after oral administration of QLC7401 and active metabolites.

Study contacts

Contact information is provided by the study sponsor or research team.

Cheng qian Li, doctorate

CONTACT

[email protected]

18661806523

Yu Cao, doctorate

CONTACT

[email protected]

0532-82911767

Sponsors and collaborators

Lead sponsor

Qilu Pharmaceutical Co., Ltd.

Industry

Registry information

Official study title

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

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
Jul 20, 2025
Registry last updated
Jul 24, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.