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A Study of BEBT-701 in Patients With Mild to Moderate Hypertension and Elevated Low-Density Lipoprotein Cholesterol（LDL-C）

ConditionMild to Moderate Hypertension and Elevated Low-Density Lipoprotein Cholesterol
Trial statusRecruiting
Trial phasePhase 1, Phase 2
Trial typeInterventional
Biological sexAll
Age18-60
SponsorBeBetter Med Inc

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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).

Disqualifiers

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).

Trial design

Design model

Parallel

Treatments tested in this trial

  • BEBT-701 Injection

    Drug

    Phase I: The starting dose of BEBT-701 injection is 100 mg; the single subcutaneous doses are 100 mg, 200 mg, 400 mg, 800 mg, and 1200 mg. Phase II: Based on the preliminary Phase I findings, three dose levels will be selected for the Phase II study, with BEBT-701 injection administered subcutaneously on Day 1 and Day 85.

  • BEBT-701 Injection Placebo（0.9% Sodium Chloride Injection）

    Drug

    Phase I：BEBT-701 injection placebo, administered as a single subcutaneous dose. Phase II:BEBT-701 injection placebo administered subcutaneously on Day 1 and Day 85.

Treatment groups

340 Participants
are divided into 4 treatment groups
Group A: Phase I Single-Dose Cohorts (BEBT-701)Experimental treatment 1 intervention
Group B: Phase I Single-Dose Cohorts (Placebo)Placebo comparator 1 intervention
Group C: Phase II Multiple-Dose Cohorts (BEBT-701)Experimental treatment 1 intervention
Group D: Phase II Multiple-Dose Cohorts (Placebo)Placebo comparator 1 intervention

Trial outcomes

Primary outcomes

1

Occurrence of Adverse Events (AEs)

Occurrence of AEs will be graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events Version 5.0 (NCI CTCAE V5.0).

Time frame
Up to 36 months
2

Low-Density Lipoprotein Cholesterol(LDL-C)

Percentage change from baseline in LDL-C after dosing.

Time frame
Up to 24 weeks
3

24hour-Ambulatory Blood Pressure Monitoring（24h-ABPM）

Change from baseline in mean 24h-ABPM systolic blood pressure (SBP) after dosing.

Time frame
Up to 24weeks

Secondary outcomes

1

AUC0-∞

The area under the plasma concentration-time curve from time zero to infinity.

Time frame
Phase I:From pre-dose to 72 h post-dose on Day 1; Phase II:From pre-dose to 72 h post-dose on Day 1and Day 85.
2

Cmax

The maximum plasma drug concentration

Time frame
Phase I:From pre-dose to 72 h post-dose on Day 1; Phase II:From pre-dose to 72 h post-dose on Day 1and Day 85.
3

Tmax

The time to reach maximum plasma drug concentration

Time frame
Phase I:From pre-dose to 72 h post-dose on Day 1; Phase II:From pre-dose to 72 h post-dose on Day 1and Day 85.
4

t1/2

The time for plasma drug concentration to halve

Time frame
Phase I:From pre-dose to 72 h post-dose on Day 1; Phase II:From pre-dose to 72 h post-dose on Day 1and Day 85.

Other outcomes

1

Immunogenicity parameters

Anti-drug antibodies(ADA), interleukin-2(IL-2), interleukin-4(IL-4), interleukin-6(IL-6), interleukin-10(IL-10), interferon-gamma(IFN-γ), tumor necrosis factor-alpha(TNF-α), complement 3(C3)and complement 4(C4).

Time frame
Up to 36 weeks

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

BeBetter Med Inc

Lead sponsor

Source ClinicalTrials.gov
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