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

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Primary Hypercholesterolemia or Combined Hyperlipidemia Characterized by Elevated LDL-C
• Intervention / Treatment: Drug: QLC7401 injection; Drug: RBD7022 injection

• Study Type: Interventional
• Enrollment (Estimated): 48
• Phase: Phase 1

Contacts and Locations

• Study Contact: Name: Yu Cao, doctorate; Phone Number: 0532-82911767; Email: Caoyu1767@126.com
• Study Contact Backup: Name: Cheng qian Li, doctorate; Phone Number: 18661806523; Email: Lichengqian5213@163.com

Study Locations

• China
  • Qingdao, China
    • The Affiliated Hospital of Qingdao University.
    • Contact: Yu Cao

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: QLC7401 injection	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.
Experimental: RBD7022 injection	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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Cmax	Maximum plasma concentration of QLC7401 and active metabolites.	0.25, 0.5, 1, 2, 4, 6, 8, 12, 24, 48 hours post dose
AUC	Area under the concentration-time curve of QLC7401 and active metabolites.	0.25, 0.5, 1, 2, 4, 6, 8, 12, 24, 48 hours post dose
Tmax	Time of maximum observed concentration of QLC7401 and active metabolites..	0.25, 0.5, 1, 2, 4, 6, 8, 12, 24, 48 hours post dose
t1/2	Terminal elimination half-life of QLC7401 and active metabolites.	0.25, 0.5, 1, 2, 4, 6, 8, 12, 24, 48 hours post dose
CL/F	Apparent total clearance of the drug from plasma after oral administration of QLC7401 and active metabolites.	0.25, 0.5, 1, 2, 4, 6, 8, 12, 24, 48 hours post dose
VZ/F	Apparent volume of distribution after oral administration of QLC7401 and active metabolites.	0.25, 0.5, 1, 2, 4, 6, 8, 12, 24, 48 hours post dose

Collaborators and Investigators

• Sponsor: Qilu Pharmaceutical Co., Ltd.

Study record dates

Study Major Dates

• Study Start (Estimated): July 1, 2025
• Primary Completion (Estimated): January 1, 2026
• Study Completion (Estimated): January 1, 2026

Study Registration Dates

• First Submitted: July 10, 2025
• First Submitted That Met QC Criteria: July 10, 2025
• First Posted (Actual): July 20, 2025

Study Record Updates

• Last Update Posted (Actual): July 24, 2025
• Last Update Submitted That Met QC Criteria: July 20, 2025
• Last Verified: July 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Metabolic Diseases; Dyslipidemias; Lipid Metabolism Disorders; Hypercholesterolemia; Hyperlipidemias
• Other Study ID Numbers: QLC7401-102

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No