Panic DisorderPhase 2NCT06483789

Efficacy and Safety of HB-1 for Panic Disorder

A Phase 2 study testing HB-1, Telmisartan Only Product in Oral Dose Form and Verapamil Only Product in Oral Dose Form in people with Panic Disorder and Mental Illness, run by HB BioTech, LLC at 19 sites in Australia.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record

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Trial 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. Read more about this study

Who is it for?: Ages 18 to 65 years
Conditions the study is for: Panic Disorder, Mental Illness
What is being tested?: HB-1, Telmisartan Only Product in Oral Dose Form and Verapamil Only Product in Oral Dose Form
Type of treatment: Pill or oral medicine
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 170 participants
Where: 19 sitesAustralia
Study dates: 29 Oct 2024to 9 Sep 2026
Phase: Phase 2
Are there results?: None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 to 65 years
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

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.

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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.

Who cannot join

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].

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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.
Documented contraindication to taking telmisartan or verapamil: (e.g., Duchenne's muscular dystrophy, myasthenia gravis).
Pregnant or breastfeeding.
Participation in another current clinical trial or prior trial within the last three months.
Urinalysis evidence of exposure to substances that may interfere with HB-1 testing (per investigator discretion).

Trial locations and contacts

19 sites in 1 country.

City, postcode or hospital

19 sites in 1 country

Australia19 sites

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

Other trials in Australia

About this study

Official title: 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.

Read the 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.

Conditions: Panic Disorder, Mental Illness
Being tested: HB-1, Telmisartan Only Product in Oral Dose Form, Verapamil Only Product in Oral Dose Form, Placebo
Medical subject headings: Panic Disorder, Mental Disorders

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

HB-1Drug
Also called Fixed dose Telmisartan / Verapamil tablet
HB-1 will be supplied as a dual active pharmaceutical ingredient tablet.
Telmisartan Only Product in Oral Dose FormDrug
Also called Telmisartan
Telmisartan will be supplied as a single active pharmaceutical ingredient tablet.
Verapamil Only Product in Oral Dose FormDrug
Also called Verapamil
Verapamil will be supplied as a single active pharmaceutical ingredient tablet.
PlaceboDrug
Also called Matched Placebo
Matched Placebo will be supplied as a tablet.

Study groups in NCT06483789
Study group	Role	What they receive
HB-1	Experimental	HB-1 fixed dose, once daily. Receives: Drug: HB-1
Telmisartan	Experimental	Telmisartan fixed dose, once daily. Receives: Drug: Telmisartan Only Product in Oral Dose Form
Verapamil	Experimental	Verapamil fixed dose, once daily. Receives: Drug: Verapamil Only Product in Oral Dose Form
Placebo	Placebo comparator	Placebo treatment, once daily Receives: Drug: Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

Number of Unexpected Panic Attacks
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.
Measured: 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
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.
Measured: 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)
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).
Measured: Baseline, Week 4, Week 8 and Week 12
Change in Panic Disorder Symptom Severity Scale (PDSS)
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.
Measured: Screening, Week 4, Week 8 and Week 12

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

29 Oct 20249 Sep 2026

First posted3 Jul 2024
Study start29 Oct 2024
Primary completion9 Sep 2026
Study completion9 Sep 2026

Why it stopped: Decision to terminate study due to a lack of efficacy in this study population. There were no safety concerns identified that contributed to this decision.

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Other trials for Panic DisorderStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 2
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Model description: 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.
Masking: Triple blind
Who is masked: Participant, Care provider, Investigator
Enrolment: 170 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT06483789
Sponsor's protocol ID: HB-PD-002
Status last verified: Sep 2026
First submitted: 26 Jun 2024
Last updated: 24 Sep 2026
Results posted: No
Data monitoring committee: No
FDA-regulated drug: Yes
FDA-regulated device: No
Individual data sharing: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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All Panic Disorder trials

Study at a glance

From the registry record, last updated by the sponsor on 24 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Efficacy and Safety of HB-1 for Panic Disorder: A Multicenter, Randomized, Double-Blind, Placebo-Controlled Trial
ClinicalTrials.gov ID: NCT06483789
Acronym / sponsor ID: HB-PD-002
Conditions: Panic Disorder, Mental Illness
Phase: Phase 2
Study type: Interventional
Recruitment status: TerminatedReason stopped: Decision to terminate study due to a lack of efficacy in this study population. There were no safety concerns identified that contributed to this decision.
Enrolment: 170 participants (actual)
Lead sponsor: HB BioTech, LLCIndustry (pharma, biotech, devices)
Study start: 29 Oct 2024 (actual)
Primary completion: 9 Sep 2026 (actual)
Study completion: 9 Sep 2026 (actual)
First posted: 3 Jul 2024 (actual)
Results: Not posted in the source record

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

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.

Detailed description

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 design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Triple blind (participant, care provider, investigator)
Number of arms: 4
Model description: 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.

Arm	Type	Receives
HB-1	Experimental	Drug: HB-1HB-1 fixed dose, once daily.
Telmisartan	Experimental	Drug: Telmisartan Only Product in Oral Dose FormTelmisartan fixed dose, once daily.
Verapamil	Experimental	Drug: Verapamil Only Product in Oral Dose FormVerapamil fixed dose, once daily.
Placebo	Placebo comparator	Drug: PlaceboPlacebo treatment, once daily

Who may qualify

Ages: 18 to 65 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (11 listed)

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.

Key exclusion criteria (19 listed)

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.

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
HB-1Also: Fixed dose Telmisartan / Verapamil tabletHB-1 will be supplied as a dual active pharmaceutical ingredient tablet.	Drug	HB-1
Telmisartan Only Product in Oral Dose FormAlso: TelmisartanTelmisartan will be supplied as a single active pharmaceutical ingredient tablet.	Drug	Telmisartan
Verapamil Only Product in Oral Dose FormAlso: VerapamilVerapamil will be supplied as a single active pharmaceutical ingredient tablet.	Drug	Verapamil
PlaceboAlso: Matched PlaceboMatched Placebo will be supplied as a tablet.	Drug	Placebo

Primary outcome

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.
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.

2 secondary outcomes

Change in Clinical Global Impression-Severity Scale (CGI-S)
Time frame: 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

Results and safety

The study was stopped early (reason given: Decision to terminate study due to a lack of efficacy in this study population. There were no safety concerns identified that contributed to this decision.). Results are not available in the source record.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 24 Sep 2026.
Individual participant dataSharing planned: No

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Prof. Malcolm Hopwood principal investigator

Ramsay Clinic Albert Road

19 sites in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 11 inclusion and 19 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: stopped early, as of the sponsor's last update on 24 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 19 sites in Australia. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

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). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06483789.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Sep 2026.