This Phase I/II clinical trial is designed to evaluate, through a single-dose Phase I segment and a multiple-dose Phase II segment, the safety/tolerability, pharmacokinetic (PK) profile, and pharmacodynamic (PD) characteristics of BEBT-701 administered by subcutaneous injection in patients with mild to moderate hypertension and elevated LDL-C , and to explore its preliminary efficacy.
Male or female aged 18 to 60 years (inclusive).
Subjects with essential hypertension who are either treatment-naive or have remained off any antihypertensive medication for ≥ 30 days prior to screening and in whom the investigator deems no additional antihypertensive therapy necessary during the study period.
Body-mass index (BMI) 18.6-30kg/m² (inclusive); body weight ≥ 50 kg for men and ≥ 45 kg for women.
Has maintained a stable diet for at least 4 weeks before screening and has no plan to make a clinically significant change in diet or body weight during the study (a change > 10 % is considered significant).
Any history of severe illness-apart from hypertension and hyperlipidemia-that in the investigator's opinion could influence trial outcomes, including but not limited to diseases of the circulatory system (e.g., orthostatic hypotension, NYHA class II-IV heart failure, aortic stenosis, major aortic aneurysm or dissection, hypertensive encephalopathy, acute stroke, transient ischemic attack, acute myocardial infarction, significant arrhythmias), endocrine, neurologic, gastrointestinal, genitourinary, hematologic, immunologic, psychiatric, or metabolic disorders.
History of allergic disease or atopic diathesis (≥3 drug or food allergies), or known hypersensitivity to oligonucleotide-based therapeutics.
Use of anti-PCSK9 or anti-AGT antibody agents within 6 months before screening, or of PCSK9- or AGT-targeted oligonucleotide drugs within 12 months before screening.
Malignancy within 5 years before informed-consent signature (exceptions: adequately resected and cured basal- or squamous-cell skin carcinoma, cervical carcinoma in situ, or other cancers considered cured by surgery alone).