Pharmacokinetics and Pharmacodynamics Study

NCT ID: NCT07074236

Last Updated: 2025-07-24

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

NOT_YET_RECRUITING

Clinical Phase

PHASE1

Total Enrollment

48 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-07-31

Study Completion Date

2026-01-31

Brief Summary

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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.

Detailed Description

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Conditions

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Primary Hypercholesterolemia or Combined Hyperlipidemia Characterized by Elevated LDL-C

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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QLC7401 injection

Group Type EXPERIMENTAL

QLC7401 injection

Intervention Type DRUG

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 injection

Group Type EXPERIMENTAL

RBD7022 injection

Intervention Type DRUG

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.

Interventions

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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.

Intervention Type 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.

Intervention Type DRUG

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Qilu Pharmaceutical Co., Ltd.

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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The Affiliated Hospital of Qingdao University.

Qingdao, , China

Site Status

Countries

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China

Central Contacts

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Yu Cao, doctorate

Role: CONTACT

0532-82911767

Cheng qian Li, doctorate

Role: CONTACT

18661806523

Facility Contacts

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Yu Cao

Role: primary

Other Identifiers

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QLC7401-102

Identifier Type: -

Identifier Source: org_study_id

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