Phase 2
N=83
Safety and Efficacy of HB-1 for Panic Disorder
Panic Disorder
Bottom Line
View on ClinicalTrials.gov: NCT05071430 ↗Enrolled (actual)
83
Serious AEs
0.0%
Results posted
Mar 2025
Primary outcome: Primary: Incidence of Treatment-Emergent Adverse Events — 23; 15 Participants
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- HB-01 (Drug); Placebo (Drug)
- Age
- Adult · 18+ yrs
- Sex
- All
- Sponsor
- HB BioTech, LLC
- Primary completion
- Dec 2022
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Incidence of Treatment-Emergent Adverse Events |
23; 15 | — |
| PRIMARY Change in Panic Disorder Symptom Severity Scale (PDSS) |
35; 35 | — |
| PRIMARY Change in Clinical Global Impression-Severity Scale (CGI-S) |
2.95; 3.33 | — |
| SECONDARY Number of Panic Attacks |
17; 10 | — |
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.
Eligibility Criteria
- Inclusion Criteria
- 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.
- Exclusion Criteria:
- 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 pr
Data sourced from ClinicalTrials.gov (NCT05071430). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.