Safety and Efficacy of HB-1 for Panic Disorder

NCT05071430 | Completed Phase 2 Results FDA Drug

• 1 other identifier: HB-001
• Study Type: interventional
• Target: 86
• Locations: 1 country
• Sites: 10

Brief 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.

Conditions

Panic Disorder

Keywords

panic; mental illness

Outcome Measures

Primary Outcomes (3)

• 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.

  Up to 12 weeks

• Change in Panic Disorder Symptom Severity Scale (PDSS)

  Percentage of patients who achieved panic free status after 12 weeks"

  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".

  Up to 12 weeks

Secondary Outcomes (1)

• Number of Panic Attacks

  Up to 12 weeks

Study Arms (2)

Active Treatment (HB-01)

ACTIVE COMPARATOR

Approximately 40 patients will receive HB-01 active study drug.

Drug: HB-01

Placebo Treatment

PLACEBO COMPARATOR

Approximately 40 patients will receive a matched placebo.

Drug: Placebo

Interventions

HB-01 DRUG

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

Also known as: Active Drug

Active Treatment (HB-01)

Placebo DRUG

HB-1 matched placebo

Placebo Treatment

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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.
• 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.

You may not qualify if:

• 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.
• 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.

Sponsors & Collaborators

• Honeybrains Biotech LLC: lead
• Cognitive Research Corporation: collaborator

Study Sites (10)

Collaborative Neuroscience Research

Garden Grove, California, 92845, United States

Location

Lumos Psychiatric Services

San Jose, California, 95124, United States

Location

Institute of Living

Hartford, Connecticut, 06106, United States

Location

CNS Healthcare

Jacksonville, Florida, 32256, United States

Location

CNS Healthcare

Orlando, Florida, 32801, United States

Location

Uptown Research Institute

Chicago, Illinois, 60640, United States

Location

Hassman Research Institute

Berlin, New Jersey, 08009, United States

Location

SPRI Clinical Trials

Brooklyn, New York, 11235, United States

Location

Richmond Behavioral Associates

Staten Island, New York, 10312, United States

Location

CNS Healthcare

Memphis, Tennessee, 38119, United States

Location

MeSH Terms

Conditions

Panic Disorder; Mental Disorders

Interventions

Bulk Drugs

Condition Hierarchy (Ancestors)

Anxiety Disorders

Intervention Hierarchy (Ancestors)

Pharmaceutical Preparations

Results Point of Contact

• Title: Tomer Seifan
• Organization: HB Biotech

tomer.seifan@hbbio.com

917-685-7351

Study Officials

• David Walling

  Collaborative NeuroScience Research, Garden Grove, CA

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: Yes

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 80 patients is planned for the study to be randomized in a 1:1 ratio of active to control.

Study Record Dates

• First Submitted: September 13, 2021
• First Posted: October 8, 2021
• Study Start: February 3, 2022
• Primary Completion: December 12, 2022
• Study Completion: December 12, 2022
• Last Updated: March 18, 2025
• Results First Posted: March 18, 2025

Record last verified: 2025-02

Data Sharing

• IPD Sharing: Will not share

Locations

US (10)