Dyslipidemia with elevated Lp(a)
Conditions
Interventions
Experimental group:Lecove ?Inclisiran was injected subcutaneously
Experimental group 2:Subcutaneous injection of FB7023
Control group:Subcutaneous injection of placebo
Sponsors
Zhejiang Xiaoshan Hospital
Eligibility
Sex/Gender
All
Age
18 Years to 55 Years
Inclusion criteria
Inclusion criteria: 1. Healthy participants aged 18 to 55 years old, regardless of gender; 2. Weight >= 50 kg (for men) / 45 kg (for women), with a body mass index (BMI) ranging from 19 to 30 kg/m^2 (inclusive of 19 and 30 kg/m^2); 3. Serum Lp(a) >= 300 mg/L at the screening stage; 4. Serum LDL-C >= 100 mg/dL (>= 2.59 mmol/L) at the screening stage; 5. Triglyceride (TG) < 400 mg/dL (< 4.52 mmol/L) at the screening stage; 6. Participants should have normal (or abnormal but without clinical significance) laboratory results, including blood routine, blood biochemistry, coagulation indicators and urine routine; 7. Participants should have normal (or abnormal without clinical significance) physical examination, vital signs, chest X-ray and electrocardiogram; 8. For pregnant women of childbearing age, the serum pregnancy test should be negative at the time of enrollment; 9. Participants agree not to have a childbearing plan during the study period and within 6 months after medication, and can take effective contraceptive measures.
Exclusion criteria
Exclusion criteria: 1. Currently undergoing lipid-lowering treatment; 2. Those with a history or clinical evidence of peripheral neuropathy; 3. Those with major cardiovascular diseases, neurological disorders, hematological diseases, infectious diseases, mental disorders, liver diseases, gastrointestinal diseases, endocrine diseases, immune diseases or kidney diseases, or a history of any of these diseases, or having known symptoms that may interfere with the absorption, distribution, metabolism or excretion of the drug, or other conditions that the investigator considers may increase the risk for the participants; 4. Those with a history of cardiovascular diseases (including peripheral artery and cerebrovascular diseases); 5. Those with hypertension or whose blood pressure is assessed by the investigator as abnormal with clinical significance; 6. Those with a history or clinical evidence of diabetes, or whose blood sugar is assessed by the investigator as abnormal with clinical significance; 7. At the time of screening, eGFR = 1.2 times the upper limit of normal (ULN) or total bilirubin >= 1.2 ULN; 13. At the time of screening, having any of the following abnormal ECG results, and judged by the investigator to be clinically significant: (1) PR > 220ms or PR = 450ms (male), QTcF >= 470ms (female) (3) QRS > 110ms; 14. Those who have donated blood or lost blood >= 400 ml within 3 months before the administration of the study drug, or have received blood transfusion; those who have donated blood (including component blood donation) or lost blood >= 200 ml within 1 month before the administration of the study drug; 15. Those who have used any siRNA drug within 12 months before administration; 16. Those who are heavy drinkers or who frequently drink alcohol within 3 months before the trial, that is, consuming more than 14 units of alcohol per week (1 unit = 360 ml of beer or 45 ml of 40% alcohol spirits or 150 ml of wine); or have a history of drug abuse; 17. Those who were moderate to heavy smokers (average daily smoking > 10 cigarettes or equivalent amount of nicotine) within 6 months before screening, including cigarettes, electronic cigarettes, and nicotine replacement products; 18. Those who cannot tolerate or due to related abdominal scars (surgery, burns, etc.) cannot undergo subcutaneous (SC) injection; 19. Any situation that the investigator considers to potentially violate trial compliance or affect the safety and efficacy evaluation.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Safety Evaluation; | — |
Secondary
| Measure | Time frame |
|---|---|
| Efficacy Evaluation;Pharmacodynamics (PD) Evaluation; | — |
Countries
China
Contacts
Public ContactJinliang Chen;Jia Yu
Zhejiang Xiaoshan Hospital
Outcome results
None listed