SA030 Injection in Healthy Participants

Inclusion Criteria:

• Participants aged 18 to 55 years, with a BMI of 25-40 kg/m².
• Healthy participants as determined by medical history, physical examination, vital signs, ECG and laboratory assessments.
• Willing to use effective contraception and have no pregnancy plans from screening to 6 months after study drug administration and/or throughout the study, with no intent to donate sperm or ova.

Exclusion Criteria:

• Medical history：

  • Nervous, cardiovascular, hematologic/lymphatic, immune, gastrointestinal, renal, respiratory, endocrine disorders, history of malignancy, or psychiatric/psychological conditions
  • Has hypertension at screening (blood pressure ≥150/95 mmHg), diabetes mellitus (FPG ≥7.0 mmol/L and/or HbA1c ≥7.0%), hyperlipidemia (LDL-C ≥4.9 mmol/L or TG ≥500 mg/dL (5.65 mmol/L)), or gout.
  • Has a history of bleeding disorders, recent active bleeding, or clinically significant bleeding risk; or has coagulation abnormalities deemed clinically significant by the Investigator at screening.
  • Tests positive for HBV, HCV, HIV, or syphilis (positive Treponema pallidum, excluding those with negative RPR).
  • Has undergone major surgery within 6 months prior to screening, or plans to undergo surgery during the study period.
  • Has severe infection or trauma within 4 weeks prior to screening.
  • Has clinically significant hepatic space-occupying lesions, gallbladder lesions, pancreatic or renal abnormalities identified on abdominal ultrasound at screening.
  • Has severe allergic diathesis.
  • Has prior severe intolerance to subcutaneous injection.
  • Has skin abnormalities at injection sites.
  • Has risk factors for TdP, requires concurrent use of QT/QTc-prolonging / TdP-inducing drugs, or has high-risk bundle branch block.

• Has clinically significant laboratory abnormalities at screening as judged by the Investigator.

• concomitant medications：

  • Has received live attenuated vaccine within 1 month prior to screening, or plans to receive live attenuated vaccine during the study period.
  • Has used any prescription drugs, herbal medicines, or over-the-counter medications within 14 days prior to administration of the investigational product.
  • Has used any over-the-counter medications, herbal medicines or dietary supplements that may significantly affect body weight or metabolism within 1 month prior to screening.
  • Has participated in another drug clinical trial within 3 months prior to treatment in this study or within 5 half-lives of the other investigational product ; or has prior use of siRNA or antisense oligonucleotide drugs within 6 months prior to administration of the study drug.

• Other

  • Has non-physiological blood loss ≥ 400 mL within 1 month prior to screening (including trauma, blood sampling, blood donation), or plans to donate blood during the study or within 30 days after study drug administration.
  • Has weekly alcohol intake >14 units within 3 months prior to screening ; or has a positive alcohol breath test on the day before dosing ; or is unable to abstain from alcohol during the in-hospital study period.
  • Has current or history of illicit drug use/substance abuse, or tests positive on urine drug screen on the day prior to dosing.