Panic DisorderPhase 2NCT05071430

Safety and Efficacy of HB-1 for Panic Disorder

A Phase 2 study testing HB-01 in people with Panic Disorder, run by HB BioTech, LLC at 10 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Trial summary

The purpose of this study is to determine the safety and efficacy of potential new treatment called "HB-1" versus placebo in male and female adult patients aged 18 to 60 years, inclusive, with panic disorder. Read more about this study

Who is it for?: Ages 18 to 60 years
Conditions the study is for: Panic Disorder
What is being tested?: HB-01
Type of treatment: Pill or oral medicine
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 86 participants
Where: 10 sitesUnited States
Study dates: 3 Feb 2022to 12 Dec 2022
Phase: Phase 2
Are there results?: Yes, posted in the registrySummary in the doctors' view

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 60 years
All sexes
No healthy volunteers
Adult

Who may be able to join

Male or female aged 18 to 60 years old, inclusive, at the time of informed consent.
Meets Diagnostic and Statistical Manual of Mental Disorders (DSM-5) Criteria for Panic Disorder.
Documented moderate to severe levels of symptoms at baseline (Panic Disorder Severity Scale of 13 or above)
Medically stable on current medication regimen for at least 3 months including PRN ('as needed') medications as determined by Investigator.
Willing to remain on current doses of other psychiatric medications throughout the length of the trial (unless a dose reduction is warranted due to improvement in symptoms).
Willing and able to safely stop any of the following medications prior to study trial: Inhibitors or inducers of CYP3A4 (erythromycin, ritonavir, telithromycin, rifampin), HMG-CoA (hydroxy methylglutaric acid coagulase) 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.

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Fluent in English.
Willing to take HB-1 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 patients must be surgically sterile (or have a monogamous partner who is surgically sterile) or be least 2 years postmenopausal or commits 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 patients must be sterile (biologically or surgically) or commit to the use of a reliable method of birth control (condoms with 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 patients 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

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 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.

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Unable to complete neuropsychological testing.
Diagnosis of Bipolar I, Bipolar II disorder or Schizophrenia.
History of suicidal behaviors including ideation.
Current treatment with doses of benzodiazepines that are outside the FDA-approved prescriber's information.
Already on treatment with either telmisartan or verapamil or both.
Documented prior drug allergy to either telmisartan or verapamil.
Documented contraindication to taking telmisartan or verapamil: (eg, Duchenne's muscular dystrophy, myasthenia gravis).
Documented moderate to severe substance abuse within the last 6 months (recreational cannabis use is allowed).
Pregnant or breastfeeding.

Trial locations and contacts

10 sites in 1 country.

City, postcode or hospital

10 sites in 1 country

United States10 sites

Hassman Research Institute
Berlin, New Jersey, 08009
SPRI Clinical Trials
Brooklyn, New York, 11235
Uptown Research Institute
Chicago, Illinois, 60640
Collaborative Neuroscience Research
Garden Grove, California, 92845
Institute of Living
Hartford, Connecticut, 06106
CNS Healthcare
Jacksonville, Florida, 32256
CNS Healthcare
Memphis, Tennessee, 38119
CNS Healthcare
Orlando, Florida, 32801
Lumos Psychiatric Services
San Jose, California, 95124
Richmond Behavioral Associates
Staten Island, New York, 10312

Other trials in United States

About this study

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

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 80 adult patients who meet the diagnosis of panic disorder.

The patients will be treated for 12 weeks including a 1 week safety follow up visit following the last dose of study drug.

Conditions: Panic Disorder
Being tested: HB-01, Placebo
Keywords: panic, mental illness
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-01Drug
Also called Active Drug
HB-1 will be supplied as a dual active pharmaceutical ingredient tablet.
PlaceboDrug
HB-1 matched placebo

Study groups in NCT05071430
Study group	Role	What they receive
Active Treatment (HB-01)	Active comparator	Approximately 40 patients will receive HB-01 active study drug. Receives: Drug: HB-01
Placebo Treatment	Placebo comparator	Approximately 40 patients will receive a matched placebo. Receives: Drug: Placebo

What is being measured

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

Incidence of Treatment-Emergent Adverse Events
Safety was evaluated through Adverse Event monitoring, review of clinically significant changes in routine laboratory tests, ECGs, and orthostatic vital signs. The safety results were presented as: number of subjects reporting an adverse event as percentage of study population that met the eligibility criteria.
Measured: Up to 12 weeks
Change in Panic Disorder Symptom Severity Scale (PDSS)
Percentage of patients who achieved panic free status after 12 weeks"
Measured: Up to 12 weeks
Change in Clinical Global Impression-Severity Scale (CGI-S)
CGI-S is a 7 point scale where 1 indicates "normal, not at all ill" and 7 indicates "amongst the most extremely ill patients".
Measured: Up to 12 weeks

Secondary outcomes (1)

Number of Panic Attacks
The proportion of all subjects achieving panic-free status at the end of the study.
Measured: Up to 12 weeks

Timeline

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

3 Feb 202212 Dec 2022

First posted8 Oct 2021
Study start3 Feb 2022
Primary completion12 Dec 2022
Study completion12 Dec 2022

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
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 80 patients is planned for the study to be randomized in a 1:1 ratio of active to control.
Masking: Triple blind
Who is masked: Participant, Care provider, Investigator
Enrolment: 86 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT05071430
Sponsor's protocol ID: HB-001
Status last verified: Feb 2025
First submitted: 13 Sep 2021
Last updated: 18 Mar 2025
Results posted: Yes, on ClinicalTrials.gov
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?

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All Panic Disorder trials

Study at a glance

From the registry record, last updated by the sponsor on 18 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Safety and Efficacy of HB-1 for Panic Disorder: A Multicenter, Randomized, Double Blind, Placebo-Controlled Trial
ClinicalTrials.gov ID: NCT05071430
Acronym / sponsor ID: HB-001
Conditions: Panic Disorder
Keywords: panic, mental illness
Phase: Phase 2
Study type: Interventional
Recruitment status: Completed
Enrolment: 86 participants (actual)
Lead sponsor: HB BioTech, LLCIndustry (pharma, biotech, devices)
Collaborators: Cognitive Research Corporation
Study start: 3 Feb 2022 (actual)
Primary completion: 12 Dec 2022 (actual)
Study completion: 12 Dec 2022 (actual)
First posted: 8 Oct 2021 (actual)
Results: Posted 18 Mar 2025

Clinical summary

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

Detailed description

The study will enroll approximately 80 adult patients who meet the diagnosis of panic disorder.

The patients will be treated for 12 weeks including a 1 week safety follow up visit following the last dose of study drug.

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Triple blind (participant, care provider, investigator)
Number of arms: 2
Model description: A sample size of 80 patients is planned for the study to be randomized in a 1:1 ratio of active to control.

Arm	Type	Receives
Active Treatment (HB-01)	Active comparator	Drug: HB-01Approximately 40 patients will receive HB-01 active study drug.
Placebo Treatment	Placebo comparator	Drug: PlaceboApproximately 40 patients will receive a matched placebo.

Who may qualify

Ages: 18 to 60 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult

Key inclusion criteria (11 listed)

Key exclusion criteria (15 listed)

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-01Also: Active DrugHB-1 will be supplied as a dual active pharmaceutical ingredient tablet.	Drug	Active Treatment (HB-01)
PlaceboHB-1 matched placebo	Drug	Placebo Treatment

Primary outcome

Incidence of Treatment-Emergent Adverse Events
Time frame: Up to 12 weeks
Safety was evaluated through Adverse Event monitoring, review of clinically significant changes in routine laboratory tests, ECGs, and orthostatic vital signs. The safety results were presented as: number of subjects reporting an adverse event as percentage of study population that met the eligibility criteria.
Change in Panic Disorder Symptom Severity Scale (PDSS)
Time frame: Up to 12 weeks
Percentage of patients who achieved panic free status after 12 weeks"
Change in Clinical Global Impression-Severity Scale (CGI-S)
Time frame: Up to 12 weeks
CGI-S is a 7 point scale where 1 indicates "normal, not at all ill" and 7 indicates "amongst the most extremely ill patients".

1 secondary outcome

Number of Panic Attacks
Time frame: Up to 12 weeks

Results and safety

Results posted to the registry on 18 Mar 2025, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Active Treatment (HB-01)	42	32
Placebo Treatment	41	32

Primary outcome: Incidence of Treatment-Emergent Adverse Events

Time frame: Up to 12 weeks. Count of participants. Unit: Participants

Measure	Active Treatment (HB-01) n = 42	Placebo Treatment n = 41
Value	23	15

Population analysed: Safety Population - subjects who were randomized and received at least one dose of study drug.

Primary outcome: Change in Panic Disorder Symptom Severity Scale (PDSS)

Time frame: Up to 12 weeks. Count of participants. Unit: Participants

Measure	Active Treatment (HB-01) n = 44	Placebo Treatment n = 42
Value	35	35

Population analysed: Panic Disorder Severity Scale Score (PDSS) Change from Baseline (ITT Population)

Primary outcome: Change in Clinical Global Impression-Severity Scale (CGI-S)

Time frame: Up to 12 weeks. Mean (Standard Deviation). Unit: score on a scale

Measure	Active Treatment (HB-01) n = 42	Placebo Treatment n = 41
Value	2.95 (1.053)	3.33 (0,986)

Population analysed: 3 subjects withdrew before dosing: only 83 treated.

1 secondary outcome is reported in the full results.

Adverse events

Time frame: Up to 12 weeks.. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Active Treatment (HB-01)	0 of 42 (0%)	23 of 42 (54.8%)	0 of 42
Placebo Treatment	0 of 41 (0%)	15 of 41 (36.6%)	0 of 41

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 18 Mar 2025.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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.

David Walling principal investigator

Collaborative NeuroScience Research, Garden Grove, CA

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

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing HB-01 in people with Panic Disorder, run by HB BioTech, LLC at 10 sites in United States.

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 15 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: finished, as of the sponsor's last update on 18 Mar 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 10 sites in United States. 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?

Yes. Results are posted in the registry (first posted 18 Mar 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

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?

Incidence of Treatment-Emergent Adverse Events (time frame: Up to 12 weeks). The study lists 3 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 NCT05071430.

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 18 Mar 2025.