NCT07074236

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

• Status: Not Yet Recruiting
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 48 (estimated)
• Sponsor: Qilu Pharmaceutical Co., Ltd. · Industry
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Accepted

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.

Conditions

• Primary Hypercholesterolemia or Combined Hyperlipidemia Characterized by Elevated LDL-C

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2025-07-01
• Primary completion: 2026-01-01
• Completion: 2026-01-01
• First posted: 2025-07-20
• Last updated: 2025-07-24

Locations

1 site across 1 country: China