Primary Hypercholesterolemia or Combined Hyperlipidemia Characterized by Elevated LDL-C
Investigational drug(s) / intervention(s)
QLC7401 injectionRBD7022 injection
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.
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.
Study 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.
Eligibility
Sex
ALL
Min age
18 Years
Max age
65 Years
Healthy volunteers
Accepted
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.
Primary outcome measure(s)
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.
Trial sites (1)
Facility
City
Region
Status
The Affiliated Hospital of Qingdao University.
Qingdao
China
More Qilu Pharmaceutical Co., Ltd. trials in China
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
We use cookies to analyse site traffic and improve your experience. With your consent, we may also use cookies for advertising. You can change your choice at any time on our Cookie Policy page. See also our Privacy Policy.