Pharmacokinetics and Pharmacodynamics Study

Phase 1Not Yet RecruitingNCT07074236

Qilu Pharmaceutical Co., Ltd.48 enrolled

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Primary Hypercholesterolemia or Combined Hyperlipidemia Characterized by Elevated LDL-C

Interventions

QLC7401 injectionDRUG

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 injectionDRUG

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.

Eligibility

Sex: ALLMin age: 18 YearsMax age: 65 YearsHealthy volunteers:

Medical Language ↔ Plain English

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.

Locations (1)

The Affiliated Hospital of Qingdao University.

Qingdao, China