Hyperlipidemia
Conditions
Interventions
A:35 mg SAL003 subcutaneously
B:70 mg SAL003 subcutaneously, or 70 mg SAL003 intravenously or placebo
C:140 mg SAL003 or Evolocumab subcutaneously, or 140 mg SAL003 intravenously
D:280mg SAL003 or placebo subcutaneously
E:420mg SAL003 or Evolocumab subcutaneously
Sponsors
Center for Clinical Pharmacology, the Third Xiangya Hospital, Central South University
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Volunteers must meet all of the following criteria to be selected: 1) Aged 18 ~ 45 years (including threshold), both men and women; 2) The weight of male volunteers is >= 50.0 kg, the weight of female volunteers is >= 45.0 kg, and the body mass index (BMI) is between 19.0 and 26.0 kg / m2, including the threshold; 3) Volunteers voluntarily sign written informed consent.
Exclusion criteria
Exclusion criteria: Volunteers who meet one or more of the following criteria will be excluded: 1) Anyone who has suffered from any serious clinical disease such as the circulatory system, endocrine system, nervous system, digestive system, respiratory system, urogenital system, hematology, immunology, psychiatry and metabolic abnormalities, or who can interfere with the test results Any other illness; 2) People with a history of headache or migraine; 3) People with a history of recurrent nausea or vomiting; 4) Have a history of allergies to drugs, food or other substances; 5) Those who have undergone surgery within 4 weeks before the trial, or plan to undergo surgery during the study period, or have undergone surgery that will affect drug absorption, distribution, metabolism, and excretion; 6) Those who have taken any drugs or health products (including Chinese herbal medicine) within 14 days before the test; 7) Any drug that inhibits or induces liver metabolism (eg: inducerbarbiturates, carbamazepine, phenytoin, glucocorticoids, omeprazole); inhibitorsSSRI-type anti-inflammatory drugs Depressants, Cimetidine, Diltiazem, Macrolides, Nitroimidazoles, Sedative Hypnotics, Verapamil, Fluoroquinolones, Antihistamines, Clarithromycin, Nefazodone, Rito (Navi and Atazanavir); 8) Those who participated in any clinical trials and took any clinical trial drugs within 3 months before the trial, or had received any treatment for the target of the proprotein-converting enzyme subtilisin 9 (PCSK9); 9) Those who donated blood or suffered heavy blood loss ( >= 200 mL), received blood transfusions, or used blood products within 3 months before enrollment; 10) pregnant or lactating women; 11) Volunteers have unprotected sex within 2 weeks before screening, and they have a reproductive plan during the trial and within 6 months after the trial is unwilling to take one or more non-drug contraceptives; 12) Those who have special requirements on diet and cannot follow a unified diet; 13) Those who drink excessive amounts of tea, coffee or caffeinated beverages (more than 8 cups, 1 cup = 250 mL) daily for 3 months before the test; 14) Smokers or those who smoked more than 5 cigarettes per day in the 3 months before the trial or who could not stop using any tobacco products during the trial; 15) Alcoholics (referred to as men drinking 5 units or more and women drinking 4 units or more within 2 hours) or regular drinkers within 6 months before the test, ie drinking more than 14 units of alcohol per week (1 unit = 360 mL beer Or 45 mL of spirits or 150 mL of wine with an alcohol content of 40%) or those who cannot stop using any alcoholic products during the test; 16) Drug abusers or those who used soft drugs (such as marijuana) 3 months before the test or who took hard drugs (such as cocaine, phencyclidine, etc.) 1 year before the test; 17) Those with abnormal vital signs (systolic blood pressure 140 mmHg, diastolic blood pressure 90 mmHg; heart rate 100 bpm) or abnormalities in physical examination, electrocardiogram, and laboratory examination are of clinical significance Based on the judgment of the clinical research doctor); 18) Those who cannot tolerate venipuncture blood collection; 19) Low-density lipoprotein cholesterol (LDL-C) level during screening is 4.14 mmol / L; 20) Volunteers may not be able to complete the study for other reasons or those the investigator believes should not be included.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Blood concentration;Serum free PCSK9 concentration;Four blood lipids (total cholesterol, triglycerides, high-density lipoprotein cholesterol, low-density lipoprotein cholesterol);Other lipid indicators (small and dense low density lipoprotein cholesterol, non-high density lipoprotein cholesterol, apolipoprotein A1, apolipoprotein B, lipoprotein a); | — |
Countries
China
Contacts
Public ContactGuoping Yang
Center for Clinical Pharmacology, the Third Xiangya Hospital, Central South University
Outcome results
None listed