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Not yet recruiting NCT07074236

Pharmacokinetics and Pharmacodynamics Study

Phase I Interventional Primary Hypercholesterolemia or Combined Hyperlipidemia Characterized by Elevated LDL-C

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: QLC7401 injection, RBD7022 injection.
Who it may be relevant to
Registry conditions: Primary Hypercholesterolemia or Combined Hyperlipidemia Characterized by Elevated LDL-C. Basic parameters: 18 years — 65 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
China
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official 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

Overview

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.

Interventions

  • Drug QLC7401 injection
    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.
  • Drug RBD7022 injection
    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 outcome measures

  • Cmax [Time frame: 0.25, 0.5, 1, 2, 4, 6, 8, 12, 24, 48 hours post dose]
  • AUC [Time frame: 0.25, 0.5, 1, 2, 4, 6, 8, 12, 24, 48 hours post dose]
  • Tmax [Time frame: 0.25, 0.5, 1, 2, 4, 6, 8, 12, 24, 48 hours post dose]
  • t1/2 [Time frame: 0.25, 0.5, 1, 2, 4, 6, 8, 12, 24, 48 hours post dose]
  • CL/F [Time frame: 0.25, 0.5, 1, 2, 4, 6, 8, 12, 24, 48 hours post dose]
  • VZ/F [Time frame: 0.25, 0.5, 1, 2, 4, 6, 8, 12, 24, 48 hours post dose]

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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: Yes

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Open label
Primary purpose
Treatment

Study locations

China · 1 center
  • The Affiliated Hospital of Qingdao University. — Qingdao

Identifiers

NCT: NCT07074236 · QLC7401-102

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗