A Randomized, Double-blind, Placebo-controlled Phase I/II Clinical Trial to Evaluate the Safety, Tolerability, Pharmacokinetics, and Preliminary Efficacy of Subcutaneous BEBT-701 in Patients With Mild to Moderate Hypertension and Elevated LDL-C
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).
• Agrees to use a highly effective method of contraception and to avoid becoming a parent from enrollment until 12 months after the last dose.
• Able to understand the study requirements, willing to comply, and provides written informed consent.
• Phase I subjects must simultaneously meet the following criteria:
• At screening and within 24 h before randomization, the 24-h ambulatory blood-pressure monitoring shows mean systolic blood pressure (SBP) \> 130 mmHg and \< 150 mmHg.
• At screening and baseline, fasting serum LDL-C is ≥ 100 mg/dL (2.6 mmol/L) and \< 190 mg/dL (4.9 mmol/L) in subjects who are either lipid-lowering-therapy-naive or have not received any lipid-lowering drug within 30 days before screening and whom the investigator judges will not require any additional lipid-lowering therapy during the study.
• Phase II subjects must simultaneously meet the following criteria:
• At screening and within 24h before randomization, 24-h ambulatory blood-pressure monitoring must show mean SBP \> 130 mmHg and \< 160 mmHg.
⁃ At screening and baseline, fasting serum LDL-C ≥ 100 mg/dL (2.6 mmol/L). Subjects already on statin therapy must have been on a stable statin dose and regimen for at least 30 days prior to screening and must have no planned changes to their statin treatment during the study.