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HB-1 治疗恐慌症的功效和安全性：多中心、随机、双盲、安慰剂对照试验

2026年9月21日 更新者：HB BioTech, LLC

The purpose of this study is to determine the safety and efficacy of HB-1, versus placebo and two monotherapies, in male and female adult patients aged 18 to 65 years, inclusive, with Panic Disorder.

研究概览

地位

终止

条件

干预/治疗

详细说明

This is a multicenter, randomized, double-blind, placebo-controlled trial. All patients with Panic Disorder, with or without specified co-morbidities, who meet all of the inclusion and none of the exclusion criteria will be eligible. Patients and researchers will be blinded to their treatment group.

The study will enroll approximately 240 (up to 600) adult patients who meet the diagnosis of panic disorder.

Patients will be treated for 12 weeks followed by a safety follow up visit one week after their last dose of study treatment.

研究类型

介入性

注册 (实际的)

170

阶段

  • 阶段2

联系人和位置

本节提供了进行研究的人员的详细联系信息，以及有关进行该研究的地点的信息。

学习地点

  • 澳大利亚
    • Australian Capital Territory
      • Canberra、Australian Capital Territory、澳大利亚、2617
        • Paratus Clinical Research Canberra
    • New South Wales
      • Blacktown、New South Wales、澳大利亚、2148
        • Paratus Clinical Research Western Sydney
      • Charlestown、New South Wales、澳大利亚、2290
        • Novatrials
      • Darlinghurst、New South Wales、澳大利亚、2010
        • East Sydney Doctors
      • Darlinghurst、New South Wales、澳大利亚、2010
        • Momentum Clinical Research Darlinghurst
      • Miranda、New South Wales、澳大利亚、2228
        • Canopy Clinical Sutherland
      • Waitara、New South Wales、澳大利亚、2077
        • Innovate Clinical Research
      • Westmead、New South Wales、澳大利亚、2145
        • Westmead Hospital
      • Wollongong、New South Wales、澳大利亚、2500
        • Canopy Clinical Wollongong
    • Queensland
      • Herston、Queensland、澳大利亚、4006
        • Paratus Clinical Research Brisbane
      • Mackay、Queensland、澳大利亚、4740
        • Mackay Hospital and Health Service
    • South Australia
      • Adelaide、South Australia、澳大利亚、5000
        • South Australian Health and Medical Research Institute
    • Victoria
      • Carlton、Victoria、澳大利亚、3053
        • NeuroCentrix
      • Frankston、Victoria、澳大利亚、3199
        • Peninsula Therapeutic and Research Group
      • Melbourne、Victoria、澳大利亚、3004
        • Ramsay Clinic Albert Road
      • Melbourne、Victoria、澳大利亚、3004
        • Multidisciplinary Alfred Psychiatry Research Clinic
      • Northcote、Victoria、澳大利亚、3070
        • Paratus Clinical Research Melbourne
      • Torquay、Victoria、澳大利亚、3228
        • Clinical Trials Institute
    • Western Australia
      • West Perth、Western Australia、澳大利亚、6005
        • Clinitrials

参与标准

研究人员寻找符合特定描述的人，称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。

资格标准

适合学习的年龄

18年 至 65年 (成人、年长者)

接受健康志愿者

不

有资格学习的性别

全部

描述

Inclusion Criteria:

  1. Male or female aged 18 to 65 years old, inclusive, at the time of informed consent.
  2. Meets Diagnostic and Statistical Manual of Mental Disorders 5th Edition (DSM-V) Criteria for Panic Disorder.
  3. Minimum of one full, unexpected panic attack in week prior to screening (via Diagnostic and Statistical Manual of Mental Disorders 5th edition [DSM-V] based structured interview).
  4. Medically stable on current medication regimen for at least 3 months (including as needed [PRN] medications), as determined by Investigator.
  5. Willing to remain on current doses of other psychiatric medications throughout the length of the trial.
  6. Willing and able to safely stop / avoid any of the following prior to study trial: Inhibitors or inducers of CYP3A4 (grapefruit juice, erythromycin, ritonavir, telithromycin, rifampin), HMG-CoA Reductase Inhibitors (Simvastatin, Lovastatin, Atorvastatin), Beta Blockers (Timolol eyedrops, Metoprolol), Neuromuscular Blocking Agents (curare-like and depolarizing), Antihypertensive Agents (Prazosin and vasodilators, angiotensin-converting enzyme inhibitors, diuretics, beta blockers), Inhalation Anesthetics, Disopyramide, Flecainide, Quinidine, Cimetidine, Lithium, Carbamazepine, Phenobarbital, Cyclosporine, Digitalis, Aliskiren, Ramipril and Ramiprilat, aspirin, propranolol.
  7. Willing and able to safely stop / avoid sensitive P-glycoprotein inhibitors.
  8. Willing to take HB-1, telmisartan, verapamil, or placebo.
  9. Willing and able to provide informed consent indicating an understanding of the requirements of the study and a willingness to comply with scheduled visits and all study procedures.
  10. Female subjects must be surgically sterile (or have a monogamous partner who is surgically sterile) or be at least 2 years postmenopausal or commit to use 2 acceptable forms of birth control (defined as the use of an intrauterine device, a barrier method with spermicide, condoms, any form of hormonal contraceptives, or abstinence) for the duration of the study and for 4 months following the last dose of study treatment. Male subjects must be sterile (biologically or surgically) or commit to the use of a reliable method of birth control (condoms ± spermicide) for the duration of the study and for 4 months following the last dose of study treatment. Individuals who are involved exclusively in same-sex relationships are exempt from the birth control requirements but must agree to abide by the recommendations if they do engage in a heterosexual relationship.
  11. Female subjects who are women of childbearing potential (WOCBP) must have a negative pregnancy test at Screening, within 7 days of dosing with study treatment.

Exclusion Criteria:

  1. Any concomitant disease, condition, or treatment that could interfere with the conduct of the study, or that would, in the opinion of the Investigator or Sponsor, pose an unacceptable risk to the participant in the study or interfere with the interpretation of study data.
  2. Concurrent treatment with benzodiazepines (e.g. alprazolam, diazepam, clonazepam, lorazepam) as assessed by clinical interview and urine toxicology testing.
  3. Severe Agoraphobia (Panic Disorder Symptom Severity Scale (PDSS) Item 4 "agoraphobic fear/avoidance" > 2).
  4. Severe Generalized Anxiety (Hamilton Anxiety Rating Scale [HAM-A] Total Score > 23).
  5. Prior lifetime history of suicide attempt, Columbia Suicide Severity Rating Scale (C-SSRS) ≥ 4 in the past 6 months or prior lifetime history of hospitalization for depression.
  6. Diagnosis of Substance Use Disorder, Obsessive-Compulsive Disorder (OCD), Bipolar I, Bipolar II disorder or schizoaffective or other psychotic disorders (per Structure Clinical Interview for Diagnostic and Statistical Manual of Mental Disorders 5th Edition (DSM-V) [SCID-V].
  7. Severe uncontrolled cardiac disease within 6 months of Screening, including but not limited to uncontrolled hypertension, hypotension (defined as below 90/60); unstable angina; myocardial infarction (MI) or cerebrovascular accident (CVA).
  8. Any clinically significant electrocardiogram (ECG) abnormalities at screening.
  9. Inadequate hepatic function defined as total bilirubin > 1.5 × the upper limit of normal (ULN) ranges of each institution, aspartate aminotransferase (AST) and alanine aminotransferase (ALT) > 3 × the ULN range of each institution.
  10. Inadequate renal function defined as serum creatinine > 1.5 × the upper limit of normal (ULN) range of each institution and/or estimated glomerular filtration rate (eGFR) < 60.
  11. Any clinically significant abnormalities in clinical laboratory assessments as assessed by the Investigator.
  12. Any other systemic conditions or organ abnormalities that in the opinion of the Investigator may interfere with the conduct and/or interpretation of the current study.
  13. Unable to complete neuropsychological testing.
  14. Already on treatment with either telmisartan or verapamil or both.
  15. Has a history of hypersensitivity or severe allergic reaction to either telmisartan or verapamil, or any component of either licensed drug.
  16. Documented contraindication to taking telmisartan or verapamil: (e.g., Duchenne's muscular dystrophy, myasthenia gravis).
  17. Pregnant or breastfeeding.
  18. Participation in another current clinical trial or prior trial within the last three months.
  19. Urinalysis evidence of exposure to substances that may interfere with HB-1 testing (per investigator discretion).

学习计划

本节提供研究计划的详细信息，包括研究的设计方式和研究的衡量标准。

研究是如何设计的？

设计细节

  • 主要用途：治疗
  • 分配：随机化
  • 介入模型：并行分配
  • 屏蔽：三倍

武器和干预

参与者组/臂
干预/治疗
实验性的：HB-1

HB-1 fixed dose, once daily.
药品：HB-1

HB-1 will be supplied as a dual active pharmaceutical ingredient tablet.

其他名称：
  • 固定剂量替米沙坦/维拉帕米片剂
实验性的：Telmisartan

Telmisartan fixed dose, once daily.
药品：Telmisartan Only Product in Oral Dose Form

Telmisartan will be supplied as a single active pharmaceutical ingredient tablet.

其他名称：
  • 替米沙坦
实验性的：Verapamil

Verapamil fixed dose, once daily.
药品：Verapamil Only Product in Oral Dose Form

Verapamil will be supplied as a single active pharmaceutical ingredient tablet.

其他名称：
  • 维拉帕米
安慰剂比较：Placebo

Placebo treatment, once daily
药品：Placebo

Matched Placebo will be supplied as a tablet.

其他名称：
  • 匹配的安慰剂

研究衡量的是什么？

主要结果指标

结果测量
措施说明
大体时间
Number of Unexpected Panic Attacks
大体时间：Screening, Week 3, Week 4, Week 5, Week 6, Week 7, Week 8, Week 9, Week 10, Week 11, and Week 12

Efficacy will be evaluated through a comparison of the number of unexpected panic attack days (over the last 10 weeks in a 12-week treatment period) from Screening as compared to protocol-specified timepoints per protocol.
Screening, Week 3, Week 4, Week 5, Week 6, Week 7, Week 8, Week 9, Week 10, Week 11, and Week 12
Incidence of Treatment-Emergent Adverse Events
大体时间：Baseline, Week 2, Week 4, Week 6, Week 8, Week 10, Week 12 and Week 13.

Safety will be evaluated through the monitoring of Adverse Events and the review of clinically significant changes in routine laboratory tests, ECGs, and orthostatic vital signs.
Baseline, Week 2, Week 4, Week 6, Week 8, Week 10, Week 12 and Week 13.

次要结果测量

结果测量
措施说明
大体时间
Change in Clinical Global Impression-Severity Scale (CGI-S)
大体时间：Baseline, Week 4, Week 8 and Week 12

Efficacy will be evaluated through an evaluation in Clinical Global Impression Severity scale (CGI-S) scores from Baseline as compared to protocol-specified timepoints per protocol. The Clinical Global Impression Severity Scale is rated on a 7-point scale, with the severity of illness scale using a range of responses from 1 (normal) through to 7 (amongst the most severely ill patients).
Baseline, Week 4, Week 8 and Week 12
Change in Panic Disorder Symptom Severity Scale (PDSS)
大体时间：Screening, Week 4, Week 8 and Week 12

Efficacy will be evaluated through an evaluation in Panic Disorder Symptom Severity Scale (PDSS) scores from Screening as compared to protocol-specified timepoints per protocol.
Screening, Week 4, Week 8 and Week 12

合作者和调查者

在这里您可以找到参与这项研究的人员和组织。

赞助

HB BioTech, LLC

调查人员

  • 首席研究员：Prof. Malcolm Hopwood、Ramsay Clinic Albert Road

研究记录日期

这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查，以确保它们在发布到公共网站之前符合特定的质量控制标准。

研究主要日期

学习开始 (实际的)

2024年10月29日

初级完成 (实际的)

2026年9月9日

研究完成 (实际的)

2026年9月9日

研究注册日期

首次提交

2024年6月26日

首先提交符合 QC 标准的

2024年6月26日

首次发布 (实际的)

2024年7月3日

研究记录更新

最后更新发布 (实际的)

2026年9月24日

上次提交的符合 QC 标准的更新

2026年9月21日

最后验证

2026年9月1日

更多信息

与本研究相关的术语

其他相关的 MeSH 术语

其他研究编号

  • HB-PD-002

计划个人参与者数据 (IPD)

计划共享个人参与者数据 (IPD)？

不

药物和器械信息、研究文件

研究美国 FDA 监管的药品

是的

研究美国 FDA 监管的设备产品

不

在美国制造并从美国出口的产品

是的

此信息直接从 clinicaltrials.gov 网站检索，没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求，请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改，我们的网站上也会自动更新.

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