Pharmacokinetics and Pharmacodynamics Study

Not Applicable

Not yet recruiting

• Conditions: Primary Hypercholesterolemia or Combined Hyperlipidemia Characterized by Elevated LDL-C
• Interventions: Drug: QLC7401 injection; Drug: RBD7022 injection

• Registration Number: NCT07074236
• Lead Sponsor: Qilu Pharmaceutical Co., Ltd.

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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2025-07
• Study Start: 2025-07-01
• Study First Submitted: 2025-07-10
• Study First Submitted QC: 2025-07-10
• Study First Posted: 2025-07-20
• Last Update Submitted: 2025-07-20
• Last Update Posted: 2025-07-24
• Primary Completion: 2026-01
• Study Completion: 2026-01-01

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 48

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
QLC7401 injection	QLC7401 injection	-
RBD7022 injection	RBD7022 injection	-

Primary Outcome Measures

Name	Time	Method
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.
Cmax	0.25, 0.5, 1, 2, 4, 6, 8, 12, 24, 48 hours post dose	Maximum plasma concentration 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.
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.
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.
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..

Trial Locations

Locations (1)

The Affiliated Hospital of Qingdao University.; 🇨🇳 Qingdao, China