Pharmacokinetics and Pharmacodynamics Study

Qilu Pharmaceutical

Status and phase

Not yet enrolling

Phase 1

Conditions

Primary Hypercholesterolemia or Combined Hyperlipidemia Characterized by Elevated LDL-C

Treatments

Drug: RBD7022 injection

Drug: QLC7401 injection

Study type

Interventional

Funder types

Industry

Identifiers

NCT07074236

QLC7401-102

Details and patient eligibility

About

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.

Enrollment

48 estimated patients

Sex

All

Ages

18 to 65 years old

Volunteers

Accepts Healthy Volunteers

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.