Primary (familial and non-familial) hypercholesterolemia or mixed hyperlipidemia characterized by elevated LDL-C
Conditions
Interventions
Dose escalation group:Single-dose YKYY015 injection (25mg, 50mg, 100mg, 300mg, 600mg, and 900mg)
placebo group:Single dose administration of placebo injection (25mg, 50mg, 100mg, 300mg, 600mg, and 900mg)
Sponsors
The Fifth Medical Center of Chinese PLA General Hospital
Eligibility
Sex/Gender
All
Age
18 Years to 55 Years
Inclusion criteria
Inclusion criteria: 1. Understand the study procedures and methods, voluntarily participate in the trial, and sign the Informed Consent Form (ICF). 2. Age between 18 and 55 years old (inclusive) at the time of signing the ICF, regardless of gender; 3. Body Mass Index (BMI) between 18 and 26 kg/m² (inclusive), with a body weight of >=50 kg for males and >=45 kg for females; 4. Serum low-density lipoprotein cholesterol (LDL-C) >=2.7 mmol/L and <4.9 mmol/L, triglycerides (TG) <=4.5 mmol/L, and total cholesterol (TC) <7.2 mmol/L; 5. Negative blood human chorionic gonadotropin (hCG) pregnancy test results for reproductive-age women at screening; all male and reproductive-age female subjects agree to use reliable contraception methods (abstinence, previous sterilization, hormonal, and/or barrier methods) during the trial and at least 90 days after administration of the study drug; male subjects agree not to donate sperm during the trial and at least 90 days after administration of the study drug; 6. Health status confirmed through medical history, physical examination (vital signs, height, weight, head, neck, chest, abdomen, spine, limbs, and skin), laboratory tests (blood routine, reticulocytes, blood biochemistry, urine routine, coagulation function), and 12-lead electrocardiogram (ECG) examination (excluding serum TC, TG, or LDL-C elevation); no abnormalities or minor abnormalities deemed clinically insignificant by the investigator. For clinically significant abnormal laboratory test results, if there are clear and reasonable reasons, a retest within one week may be conducted to determine whether the subject meets the eligibility criteria.
Exclusion criteria
Exclusion criteria: 1. History of drug allergy; 2. Abnormalities in 12-lead ECG results judged clinically significant by the study physician or corrected QTc interval =450 ms; 3. Participation in any other clinical trial within 90 days prior to enrollment or still within the safety washout period specified by the previous clinical trial on the day of the first administration of this study; 4. History of significant disease considered clinically significant by the investigator within 90 days prior to enrollment; 5. Active or latent infections at screening, including but not limited to hepatitis B virus (HBV) infection, hepatitis C virus (HCV) infection, human immunodeficiency virus (HIV) infection, syphilis treponemal infection; 6. Elevated levels of alanine aminotransferase (ALT), aspartate aminotransferase (AST), or gamma-glutamyl transferase (GGT) more than twice the upper limit of normal (ULN), or total bilirubin more than 1.5 times ULN; 7. Estimated glomerular filtration rate (eGFR) <90 mL/min (CKD-EPI formula); 8. Frequent alcohol consumption within 3 months prior to screening, defined as daily consumption exceeding 720 mL of beer with 5% alcohol content, 90 mL of liquor with 40% alcohol content, or 300 mL of wine with 12% alcohol content; 9. History of smoking (average daily consumption of more than 5 cigarettes or equivalent electronic cigarettes within 3 months prior to screening and/or unwillingness to avoid using any tobacco products during the trial); 10. History of drug abuse or drug use; 11. History of blood donation within 3 months prior to enrollment or blood loss exceeding 400 mL or transfusion of any blood or blood products; 12. History of subcutaneous injection intolerance or related abdominal scars (from surgery, burns, etc.); 13. Other factors judged by the investigator as potentially affecting the results or interfering with the entire study process, including but not limited to other medical histories (such as history of mental disorders), vital signs, physical examination, and/or clinical laboratory abnormalities.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Adverse events (AEs and SAEs);Vital signs;Physical examination;ECG;Laboratory indicators; | — |
Secondary
| Measure | Time frame |
|---|---|
| PK;ADA;QTc; | — |
Countries
China
Contacts
Public ContactFusheng Wang; Yuanyuan Li
The Fifth Medical Center of Chinese PLA General Hospital
Outcome results
None listed