Efficacy and Safety of HB-1 for Panic Disorder

May 25, 2026 updated by: HB BioTech, LLC

Efficacy and Safety of HB-1 for Panic Disorder: A Multicenter, Randomized, Double-Blind, Placebo-Controlled Trial

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

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.

Study Type

Interventional

Enrollment (Estimated)

240

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • Australia
    • Australian Capital Territory
      • Canberra, Australian Capital Territory, Australia, 2617
        • Recruiting
        • Paratus Clinical Research Canberra
        • Principal Investigator:
          • Dr Amber Leah
        • Contact:
    • New South Wales
      • Blacktown, New South Wales, Australia, 2148
        • Recruiting
        • Paratus Clinical Research Western Sydney
        • Contact:
        • Principal Investigator:
          • Dr Aaron Wong
      • Charlestown, New South Wales, Australia, 2290
        • Recruiting
        • Novatrials
        • Contact:
        • Principal Investigator:
          • Dr Vidushi Khatri
      • Darlinghurst, New South Wales, Australia, 2010
      • Darlinghurst, New South Wales, Australia, 2010
      • Kanwal, New South Wales, Australia, 2259
        • Withdrawn
        • Paratus Clinical Research Central Coast
      • Miranda, New South Wales, Australia, 2228
        • Completed
        • Canopy Clinical Sutherland
      • Waitara, New South Wales, Australia, 2077
      • Westmead, New South Wales, Australia, 2145
      • Wollongong, New South Wales, Australia, 2500
    • Queensland
      • Herston, Queensland, Australia, 4006
        • Recruiting
        • Paratus Clinical Research Brisbane
        • Contact:
        • Principal Investigator:
          • Dr Pi Lip Seet
      • Mackay, Queensland, Australia, 4740
      • Southport, Queensland, Australia, 4215
        • Withdrawn
        • Gold Coast University Hospital
    • South Australia
      • Adelaide, South Australia, Australia, 5000
        • Recruiting
        • South Australian Health and Medical Research Institute
        • Contact:
        • Principal Investigator:
          • Dr Frances Adams
      • Elizabeth Vale, South Australia, Australia, 5112
        • Withdrawn
        • Lyell McEwin Hospital
    • Victoria
      • Ballarat, Victoria, Australia, 3350
        • Withdrawn
        • Grampians Health
      • Carlton, Victoria, Australia, 3053
        • Recruiting
        • NeuroCentrix
        • Principal Investigator:
          • Prof. David Barton
        • Contact:
      • Frankston, Victoria, Australia, 3199
        • Recruiting
        • Peninsula Therapeutic and Research Group
        • Contact:
        • Principal Investigator:
          • Dr Jennifer Grunfeld
      • Melbourne, Victoria, Australia, 3004
        • Recruiting
        • Ramsay Clinic Albert Road
        • Contact:
        • Principal Investigator:
          • Prof. Malcolm Hopwood
      • Melbourne, Victoria, Australia, 3004
        • Recruiting
        • Multidisciplinary Alfred Psychiatry Research Clinic
        • Contact:
        • Principal Investigator:
          • Dr Rebecca Ho
      • Northcote, Victoria, Australia, 3070
        • Recruiting
        • Paratus Clinical Research Melbourne
        • Contact:
        • Contact:
          • A/Prof Bernadette Fitzgibbon
        • Principal Investigator:
          • Kianoosh Noori Samie
      • Torquay, Victoria, Australia, 3228
    • Western Australia
      • West Perth, Western Australia, Australia, 6005
        • Recruiting
        • Clinitrials
        • Contact:
        • Principal Investigator:
          • Dr Zachary Nathan

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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).

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: HB-1
HB-1 fixed dose, once daily.
Drug: HB-1
HB-1 will be supplied as a dual active pharmaceutical ingredient tablet.
Other Names:
  • Fixed dose Telmisartan / Verapamil tablet
Experimental: Telmisartan
Telmisartan fixed dose, once daily.
Drug: Telmisartan Only Product in Oral Dose Form
Telmisartan will be supplied as a single active pharmaceutical ingredient tablet.
Other Names:
  • Telmisartan
Experimental: Verapamil
Verapamil fixed dose, once daily.
Drug: Verapamil Only Product in Oral Dose Form
Verapamil will be supplied as a single active pharmaceutical ingredient tablet.
Other Names:
  • Verapamil
Placebo Comparator: Placebo
Placebo treatment, once daily
Drug: Placebo
Matched Placebo will be supplied as a tablet.
Other Names:
  • Matched Placebo

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Incidence of Treatment-Emergent Adverse Events
Time Frame: 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.
Number of Unexpected Panic Attacks
Time Frame: 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

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in Clinical Global Impression-Severity Scale (CGI-S)
Time Frame: 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)
Time Frame: 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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

HB BioTech, LLC

Investigators

  • Principal Investigator: Prof. Malcolm Hopwood, Ramsay Clinic Albert Road

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

October 29, 2024

Primary Completion (Estimated)

January 1, 2027

Study Completion (Estimated)

February 1, 2027

Study Registration Dates

First Submitted

June 26, 2024

First Submitted That Met QC Criteria

June 26, 2024

First Posted (Actual)

July 3, 2024

Study Record Updates

Last Update Posted (Actual)

May 28, 2026

Last Update Submitted That Met QC Criteria

May 25, 2026

Last Verified

May 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • HB-PD-002

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

Yes

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Mental Illness

Clinical Trials on HB-1

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Congo

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe