Hypercholesterolemia and mixed dyslipidemia
Conditions
Interventions
Group A:Phase 1: 140 mg SAL003 injection was performed with a pre-filled syringe pen
Phase 2: 140 mg SAL003 injection was performed with a pre-filled syringe
Group B:Phase 1: 140 mg SAL003 injection was performed with a pre-filled syringe
Phase 2: 140 mg SAL003 injection was performed with a pre-filled syringe pen
Sponsors
Second Affiliated Hospital of Guangzhou Medical University
Eligibility
Sex/Gender
All
Age
18 Years to 65 Years
Inclusion criteria
Inclusion criteria: 1. Have fully understood and voluntarily signed the written informed consent for this study, and can abide by the requirements and restrictions listed in the informed consent; 2. Chinese male or female subjects aged 18 to 65 years old (including 18 and 65 years old); 3. At the time of screening, the body weight was >=50 kg for men and >=45 kg for women with a body mass index (BMI) between 19.0 and 26.0 kg/m^2 (including 19.0 kg/m^2 and 26.0 kg/m^2; BMI = weight/height ^2); 4. The results of screening examinations (including physical examination, vital signs, blood routine, urine routine, blood biochemistry, four coagulation tests, four infection tests, 12-lead electrocardiogram, chest X-ray, abdominal B ultrasound, etc.) were normal or slightly abnormal but judged by the investigators to be of no clinical significance. 5. subjects' LDL-C levels were in the range of 70mg/dL to 190mg/dL(1.8 to 4.9mmol/L) (including the boundary value); 6. Participants did not have unprotected sex in the two weeks prior to screening; They had no plans to become pregnant during the study and for 6 months after the last dose of study drug, voluntarily used effective contraceptive methods (contraceptive use was prohibited during the study) to avoid pregnancy for themselves or their partners, and did not donate sperm or eggs (eggs, oocytes) for reproductive or assisted reproductive purposes.
Exclusion criteria
Exclusion criteria: 1. Pregnant, lactating women, or women of childbearing age with a positive pregnancy screening result; 2. People with a known history of drug or food allergy, or allergic constitution (such as allergy to two or more drugs, food or pollen), or allergic diseases (such as asthma, urticaria, eczematous dermatitis, etc.), Or possible or definite allergy, hypersensitivity reaction or clinically significant reaction to the study drug (including similar drugs) and any excipients in the drug as judged by the investigator; 3. Hepatitis B virus surface antigen, hepatitis C virus antibody, treponema pallidum specific antibody, human immunodeficiency virus antibody test results are positive; 4. People with drug or substance abuse, alcohol or tobacco addiction;People with a history of drug abuse or positive urine drug screening results at admission;Those who had consumed an average of more than 14 units of alcohol per week in the 3 months before screening (1 unit ˜17.7 mL of ethanol, i.e., 360 mL of 5% beer, 45 mL of 40% liquor, or 150 mL of 12% wine), or who had a positive alcohol breath test on admission; Or unable to completely stop eating any food or drink containing alcohol during the study period;Subjects who smoked more than 5 cigarettes per day in the 3 months before screening; 5. subject who use of any of the following foods, drugs, or treatments prior to administration:Use of any prescription drugs, over-the-counter drugs, herbal medicines and food supplements (including vitamins, health foods, etc.) within 2 weeks before the dose; Drinking excessive amounts of tea, coffee, or caffeinated beverages (more than 8 cups per day, 1 cup =250 mL) in the 3 months before dosing; 6. Have participated or are participating in any interventional clinical study (including investigational drugs or vaccines) within 3 months before screening, have received investigational drugs, or have received any treatment against the proprotein convertase subtilisin-kexin type 9 (PCSK9) target; 7. Have received a live vaccine, live attenuated vaccine, or vaccine with any live viral component within 3 months before screening or plan to receive such vaccine during the study period; 8. Donated blood (including component donation) or had a blood loss of >=400 mL within 3 months before screening, donated blood (including component donation) or had a blood loss of >=200 mL or received a blood transfusion within 1 month before screening, or planned to donate blood or blood components during the study or within 1 month after study completion; 9. Have experienced major trauma or undergone a major surgical procedure (if general anesthesia is required) within 3 months before screening or are planning to undergo surgery (other than surgery with local anesthesia) during or within 3 months after the study; 10. Difficulty in blood collection or inability to tolerate multiple venipuncture, or a history of syncope or syncope judged by the investigator to be clinically significant; 11. There are other diseases or medical histories that are judged by the investigator to be clinically significant or likely to prevent the subject from completing the study (including systems such as: Respiratory, cardiovascular, digestive, genitourinary, hematological, endocrine, neurological, psychiatric and malignant diseases), or other diseases or medical histories that may significantly alter the absorption, metabolism or clearance of drugs (such as gastrointestinal surgery, renal surgery or ch
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Adverse events, vital signs, physical examination, laboratory tests, electrocardiogram, etc;Pharmacodynamic evaluation indicators;Evaluation index of immunogenicity;Cmax;AUCinf; | — |
Secondary
| Measure | Time frame |
|---|---|
| Tmax, t1/2, Vz/F, CL/F, AUC_%Extrap, ?z; | — |
Countries
China
Contacts
Public ContactZhihong Xie
Second Affiliated Hospital of Guangzhou Medical University
Outcome results
None listed