This is a randomized, double-blind, placebo-controlled, single ascending dose (SAD) study of SYH2070 injection when administered subcutaneously to healthy subjects.
Subjects must provide informed consent before the trial, fully understand its content, procedures, and potential adverse reactions, and voluntarily sign the written ICF;
Sex: Male or female;
Age: 18-60 years (inclusive);
Body mass index (BMI) in the range of 19 to 30 kg•m² [BMI = weight/height² (kg•m²)] (inclusive), with a weight of no less than 50 kg for males (inclusive) and no less than 45 kg for females (inclusive);
History of severe allergic diseases or allergic constitution (≥ 3 drug or food allergies), or known history of allergy to the investigational drug components (N-acetylgalactosamine, sodium hydroxide, phosphoric acid) or oligonucleotide drugs;
Use of antibody drugs and/or oligonucleotide drugs targeting PCSK9/ANGPTL3/ApoC-III within 12 months prior to screening;
Current and/or history of clinically significant medical conditions, including but not limited to circulatory, hematological or hematopoietic, respiratory, endocrine, urinary, digestive system diseases, neurological or psychiatric disorders, infections, tumors, severe trauma, or any other disease that should be excluded or may interfere with the interpretation of the study results, as judged by the investigator;
History of major surgery within 6 months prior to screening, or are scheduled to undergo major surgery during the course of the study;
Parallel
SYH2070 injection
Drugsubcutaneous injection
Placebo
Drugsubcutaneous injection
Number of Subjects with Adverse Events as Assessed by CTCAE v5.0
The serum TG level after dosing SYH2070 injection
The serum LDL-C level after dosing SYH2070 injection
Plasma Maximum concentration (Cmax)
Time to maximum concentration (Tmax)
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