Hypercholesterolemia
Conditions
Interventions
A:SHR-1918 Injection (dosage 1) vs placebo
B:SHR-1918 Injection (dosage 2) vs placebo
C:SHR-1918 Injection (dosage 3) vs placebo
D:SHR-1918 Injection (dosage 4) vs placebo
E:SHR-1918 Injection (dosage 5) vs placebo(selective)
F:SHR-1918 Injection (dosage 6) vs placebo (selective)
Sponsors
The second hospital of Anhui Medical University
Eligibility
Sex/Gender
All
Age
18 Years to 65 Years
Inclusion criteria
Inclusion criteria: 1. Male and female healthy subjects aged 18-65 years at the date of signing the informed consent (including 18 and 45 years). 2. 1.7 mmol/L= Serum TG =5.6 mmol/L or 2.6 mmol/L =Serum LDL-C <4.9 mmol/L. 3. 18.5 kg/m2=BMI<30 kg/m2, 50.0 kg/m2=Weight<90 kg for males, 45.0 kg/m2=Weight<90 kg for females. 4. No abnormalities or minor abnormalities judged by the investigator to be not clinically significant on physical examination, vital signs, 12-lead ECG, frontal and lateral chest X-ray and laboratory tests. 5. Those who understand the study procedures and methods, voluntarily participate in this trial and sign the informed consent form. For female subjects of childbearing potential and male subjects whose partners are women of childbearing potential, they are willing to abstain from abstinence or use a highly effective method of contraception from the time they sign the informed consent form to the end of the follow-up period; female subjects of childbearing potential must have a negative pregnancy test prior to administration and be non-lactating.
Exclusion criteria
Exclusion criteria: 1. The presence of a disease or treatment history: (1) A disease that, in the judgment of the investigator, interferes with the absorption, distribution, metabolism and excretion of the drug or can reduce adherence. (2) Comorbid cardiovascular, hepatic, renal, gastrointestinal, psychoneurological, hematological, or metabolic abnormalities. (3) History of clinically significant drug allergy or history of atopic allergic disease (asthma, urticaria, eczematous dermatitis) or known allergy to antibody-based drugs. (4) Persons with previous malignant neoplastic disease. (5) Those who have participated in any other clinical trial of a drug or medical device within 3 months prior to screening or are scheduled to participate in a clinical trial during the trial (except for those who have failed in screening), or who are within 5 half-lives of the drug prior to screening (whichever is longer). (6) Those who have had serious trauma or surgery within 6 months prior to screening, or who are scheduled to undergo surgery during the trial; those who have had a serious infection within 3 months prior to screening. (7) Those who have used any medication (including prescription drugs, over-the-counter medications, herbal medicines, dietary supplements and vitamin A and its derivatives, except for other conventional vitamins and occasional acetaminophen) within 2 weeks prior to screening or baseline (whichever is longer); or who are within 5 half-lives of the drug at screening (whichever is longer). 2. Any of the following criteria are met at screening. (1) Blood creatinine above the upper limit of normal (ULN). (2) Alanine aminotransferase (ALT) or aspartate aminotransferase (AST) or gamma-glutamyl transferase (GGT) exceeding 2 times ULN, or total bilirubin exceeding 1.5 times ULN. (3) Positive human immunodeficiency virus antibody (HIV-Ab), syphilis serology, hepatitis B virus surface antigen (HBsAg), hepatitis C virus antibody (HCV-Ab) during the screening period. (4) Creatine kinase (CK) above 3 times ULN. (5) Thyroid stimulating hormone (TSH) below the lower limit of normal (LLN) or above 1.5 times ULN. (6) Glomerular filtration rate (eGFR) < 70 mL/min/1.73m2 (calculated using the MDRD formula, eGFR (mL/min/1.73m2) = 175 x (serum creatinine/88.4) - 1.234 x age - 0.179 x (0.79 female), where serum creatinine units are µmol/L). 3. General conditions: (1) Persons with a history of blood donation within 3 months prior to screening, or who have had significant blood loss (=400 mL), or who have received a blood transfusion within 4 weeks. (2) Those who have received a vaccine within 2 weeks prior to screening or are scheduled to receive a vaccine during the trial. (3) Those who have started new physical activity or made significant changes to previous exercise activity within 4 weeks prior to screening, or whose exercise has not remained essentially stable during the trial. (4) Those who have made significant changes to their previous diet plan within 4 weeks prior to screening (5) Those who have consumed an average =5 cigarettes per day during the 4 weeks prior to screening (6) Those who have consumed more than 15 g of alcohol a day for women and 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) more than twice a week during the 4 weeks prior to screening or has had a positive alcohol breath test (which may be replaced by an alcohol blood test) during the screening
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Serum drug concentration;Serum TG concentration;Serum TC concentration;Serum LDL-C concentration;Serum HDL-C concentration;Serum ApoB concentration;Serum ApoA1 concentration;Serum Lp(a) concentration;serum VLDL-C concentration;ADA and Nab in serum;Adverse events;Vital signs;Physical examination;Laboratory examination;Routine 12-leads electrocardiogram;Injection site reaction; | — |
Countries
China
Contacts
Public ContactWei Hu
The second hospital of Anhui Medical University
Outcome results
None listed