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

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT07074236

Enrollment

Registered

2025-07-20

Start date

2025-07-31

Completion date

2026-01-31

Last updated

2025-07-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Primary Hypercholesterolemia or Combined Hyperlipidemia Characterized by Elevated LDL-C

Brief 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.

Interventions

DRUGQLC7401 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.

DRUGRBD7022 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.

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to 65 Years

Healthy volunteers

Yes

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.

Design outcomes

Primary

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

Countries

China

Contacts

Primary ContactYu Cao, doctorate

Caoyu1767@126.com0532-82911767

Backup ContactCheng qian Li, doctorate

Lichengqian5213@163.com18661806523

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026