Efficacy and Safety of HB-1 for Panic Disorder

NCT06483789 | Recruiting Phase 2 FDA Drug

• 1 other identifier: HB-PD-002
• Study Type: interventional
• Target: 240
• Locations: 1 country
• Sites: 22

Brief Summary

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.

Conditions

Panic Disorder; Mental Illness

Outcome Measures

Primary Outcomes (2)

• Number of Unexpected Panic Attacks

  Efficacy will be evaluated through a comparison of the number of unexpected panic attacks from Screening as compared to protocol-specified timepoints per protocol.

  Screening, Week 1, Week 2, 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

  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.

Secondary Outcomes (2)

• Change in Clinical Global Impression-Severity Scale (CGI-S)

  Baseline, Week 4, Week 8 and Week 12

• Change in Panic Disorder Symptom Severity Scale (PDSS)

  Screening, Week 4, Week 8 and Week 12

Study Arms (4)

HB-1

EXPERIMENTAL

HB-1 fixed dose, once daily.

Drug: HB-1

Telmisartan

EXPERIMENTAL

Telmisartan fixed dose, once daily.

Drug: Telmisartan Only Product in Oral Dose Form

Verapamil

EXPERIMENTAL

Verapamil fixed dose, once daily.

Drug: Verapamil Only Product in Oral Dose Form

Placebo

PLACEBO COMPARATOR

Placebo treatment, once daily

Drug: Placebo

Interventions

HB-1 DRUG

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

Also known as: Fixed dose Telmisartan / Verapamil tablet

HB-1

Verapamil Only Product in Oral Dose Form DRUG

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

Also known as: Verapamil

Verapamil

Placebo DRUG

Matched Placebo will be supplied as a tablet.

Also known as: Matched Placebo

Placebo

Telmisartan Only Product in Oral Dose Form DRUG

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

Also known as: Telmisartan

Telmisartan

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Male or female aged 18 to 65 years old, inclusive, at the time of informed consent.
• Meets Diagnostic and Statistical Manual of Mental Disorders 5th Edition (DSM-V) Criteria for Panic Disorder.
• 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).
• Medically stable on current medication regimen for at least 3 months (including as needed \[PRN\] medications), as determined by Investigator.
• Willing to remain on current doses of other psychiatric medications throughout the length of the trial.
• 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.
• Willing and able to safely stop / avoid sensitive P-glycoprotein inhibitors.
• Willing to take HB-1, telmisartan, verapamil, or placebo.
• 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.
• 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.
• 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.

You may not qualify if:

• 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.
• Concurrent treatment with benzodiazepines (e.g. alprazolam, diazepam, clonazepam, lorazepam) as assessed by clinical interview and urine toxicology testing.
• Severe Agoraphobia (Panic Disorder Symptom Severity Scale (PDSS) Item 4 "agoraphobic fear/avoidance" \> 2).
• Severe Generalized Anxiety (Hamilton Anxiety Rating Scale \[HAM-A\] Total Score \> 23).
• 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.
• 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) \[SCID-V\].
• 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).
• Any clinically significant electrocardiogram (ECG) abnormalities at screening.
• 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.
• 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.
• Any clinically significant abnormalities in clinical laboratory assessments as assessed by the Investigator.
• 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.
• Unable to complete neuropsychological testing.
• Already on treatment with either telmisartan or verapamil or both.
• Has a history of hypersensitivity or severe allergic reaction to either telmisartan or verapamil, or any component of either licensed drug.

Sponsors & Collaborators

• Honeybrains Biotech LLC: lead

Study Sites (22)

Paratus Clinical Research Canberra

Canberra, Australian Capital Territory, 2617, Australia

RECRUITING

Paratus Clinical Research Western Sydney

Blacktown, New South Wales, 2148, Australia

RECRUITING

East Sydney Doctors

Darlinghurst, New South Wales, 2010, Australia

RECRUITING

Momentum Clinical Research Darlinghurst

Darlinghurst, New South Wales, 2010, Australia

RECRUITING

Paratus Clinical Research Central Coast

Kanwal, New South Wales, 2259, Australia

RECRUITING

Novatrials

Kotara, New South Wales, 2289, Australia

RECRUITING

Canopy Clinical Sutherland

Miranda, New South Wales, 2228, Australia

RECRUITING

Innovate Clinical Research

Waitara, New South Wales, 2077, Australia

RECRUITING

Westmead Hospital

Westmead, New South Wales, 2145, Australia

RECRUITING

Canopy Clinical Wollongong

Wollongong, New South Wales, 2500, Australia

RECRUITING

Paratus Clinical Research Brisbane

Herston, Queensland, 4006, Australia

RECRUITING

Mackay Hospital and Health Service

Mackay, Queensland, 4740, Australia

RECRUITING

Gold Coast University Hospital

Southport, Queensland, 4215, Australia

RECRUITING

South Australian Health and Medical Research Institute

Adelaide, South Australia, 5000, Australia

RECRUITING

Lyell McEwin Hospital

Elizabeth Vale, South Australia, 5112, Australia

WITHDRAWN

Grampians Health

Ballarat, Victoria, 3350, Australia

WITHDRAWN

NeuroCentrix

Carlton, Victoria, 3053, Australia

RECRUITING

Peninsula Therapeutic and Research Group

Frankston, Victoria, 3199, Australia

COMPLETED

Multidisciplinary Alfred Psychiatry Research Clinic

Melbourne, Victoria, 3004, Australia

RECRUITING

Ramsay Clinic Albert Road

Melbourne, Victoria, 3004, Australia

RECRUITING

Paratus Clinical Research Melbourne

Northcote, Victoria, 3070, Australia

RECRUITING

Clinitrials

Perth, Western Australia, 6000, Australia

RECRUITING

MeSH Terms

Conditions

Panic Disorder; Mental Disorders

Interventions

Telmisartan; Verapamil; Dosage Forms

Condition Hierarchy (Ancestors)

Anxiety Disorders

Intervention Hierarchy (Ancestors)

Biphenyl Compounds; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Benzimidazoles; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Phenethylamines; Ethylamines; Amines; Pharmaceutical Preparations; Technology, Pharmaceutical; Investigative Techniques

Study Officials

• Prof. Malcolm Hopwood

  Ramsay Clinic Albert Road

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Karen Smith

CONTACT

+1-650-722-9813; karen.smith@hbbio.com

Alon Seifan

CONTACT

+1-786-620-3204; alon.seifan@hbbio.com

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Masking Details: An unblinded pharmacist will be utilized to assign bottles to each patient using an interactive voice response system (IVRS) central randomization system. Study treatment or placebo will be dispensed to patients in blinded bottles.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: A sample size of 240 patients (up to a maximum of 600) is planned for the study to be randomized in a 3:1:1:1 ratio of active to monotherapy to monotherapy to placebo control.

Study Record Dates

• First Submitted: June 26, 2024
• First Posted: July 3, 2024
• Study Start: October 29, 2024
• Primary Completion (Estimated): January 1, 2027
• Study Completion (Estimated): February 1, 2027
• Last Updated: December 10, 2025

Record last verified: 2025-06

Data Sharing

• IPD Sharing: Will not share

Locations

AU (22)