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Pharmacokinetics and Pharmacodynamics Study

NCT07074236 · Status: NOT_YET_RECRUITING · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 48

Last updated 2025-07-24

No results posted yet for this study

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

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.

Sponsors & Collaborators

  • Qilu Pharmaceutical Co., Ltd.

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2025-07-31
Primary Completion
2026-01-31
Completion
2026-01-31

Countries

  • China

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07074236 on ClinicalTrials.gov