Hyperlipidemia
Conditions
Interventions
A:Single subcutaneous injection of SHR-1209 in the predetermined area A
B:Single subcutaneous injection of SHR-1209 in the predetermined area B
C:Single subcutaneous injection of SHR-1209 in the predetermined area C
Sponsors
The Second Hospital of Anhui Medical University
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Understand the study procedures and methods, participate voluntarily and be able to complete the study following the protocol requirements, and sign the informed consent; 2. Must be >=18 years and =18.5 and =50kg and =45kg and =1.8mmol/L and <4.9 mmol/L during screening and check-in; 5. Fasting triglycerides<=5.6 mmol/L during screening and check-in; 6. Physical examination, 12-lead ECG, vital signs, orthopantomogram, abdominal ultrasound, laboratory tests (routine blood, blood biochemistry, urine routine, coagulation function, glycosylated hemoglobin, thyroid function) without abnormalities or with abnormalities but not clinically significant as judged by the investigator; 7. Subjects and their female partners are willing to have no childbearing plans and voluntarily use highly effective contraception from 2 weeks before screening to 6 months after drug administration and have no plans to donate sperm or eggs.
Exclusion criteria
Exclusion criteria: 1. Presence of the following diseases or treatment history: (1) Diseases affecting the absorption, distribution, metabolism, and excretion of drugs as determined by the investigator; (2) Diseases of the circulatory, digestive, urinary, psychoneurological, hematological, metabolic systems, etc.; (3) Pre-existing malignancies; (4) Severe infection within 3 months before screening; (5) History of drug allergy or atopic allergic disease (asthma, urticaria); (6) Serious trauma or surgery within 6 months before screening or surgery planned during the trial; (7) Previous use of SHR-1209 or other PCSK9 inhibitors within 6 months of the screening or baseline period; (8) Previous use of any medication (including prescription drugs, over-the-counter medications, herbs, vitamins, etc.) within 2 weeks prior to screening or baseline; or within 5 half-lives of the medication at screening; (9) Enrolled in any other drug or medical device clinical trial within 3 months before screening, or planning to enroll in another drug or medical device clinical trial during this trial, or still within 5 half-lives of the medication at screening. 2. Any of the following criteria are met at screening or baseline: (1) Blood creatinine above the upper limit of normal (ULN); (2) Alanine aminotransferase (ALT) or aspartate aminotransferase (AST) over 2 times ULN, or total bilirubin over 1.5 times ULN; (3) Creatine kinase (CK) above 3 times ULN; (4) Positive human immunodeficiency virus antibody (HIV-Ab), syphilis serology, hepatitis B virus surface antigen (HBsAg), hepatitis C virus antibody (HCV-Ab); (5) Thyroid-stimulating hormone (TSH) below the lower limit of normal (LLN) or above the upper limit of normal (ULN); (6) eGFR =400 mL), or having received a transfusion within 4 weeks; (2) Vaccinated within the first 4 weeks of the screening or baseline period, or planned to be vaccinated during the trial; (3) Initiation of new physical activity or significant change in previous exercise activity within 4 weeks before the screening or baseline period, or inability to maintain a substantially stable level of physical activity during the trial; (4) Significant adjustment to previous diet plan within 4 weeks before screening or baseline period, or inability to maintain a substantially stable dietary intake during the study period; (5) Smoked an average of 5 or more cigarettes per day during the 3 months before the screening period or unable to stop using any tobacco-based products during the trial; (6) Consumption of more than 15 g of alcohol a day for women or more than 25 g for men (15 g of alcohol is equivalent to 450 mL of beer, 150 mL of wine, or 50 mL of low alcohol) and more than twice a week during the 4 weeks before the screening, or inability to stop using any alcohol product during the trial; (7) History of drug abuse; (8) Women who are pregnant or breastfeeding. 4. Subjects who have any other factors deemed unsuitable for this study by the investigator.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Maximum plasma concentration;Area under the time-concentration curve;Terminal half-life;Time to reach maximum concentration;Vital signs;Laboratory examination;Routine 12-leads electrocardiogram;Physical examination;Adverse events; | — |
Countries
China
Contacts
Public ContactWei Hu
Drug Clinical Trial Research Center, The Second Hospital of Anhui Medical University
Outcome results
None listed