Safety and Efficacy of HB-1 for Panic Disorder

Phase 2

Completed

• Conditions: Panic Disorder
• Interventions: Drug: Placebo; Drug: HB-01

• Registration Number: NCT05071430
• Lead Sponsor: Honeybrains Biotech LLC

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.

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.

Study Timeline

• Study First Submitted: 2021-09-13
• Study First Submitted QC: 2021-09-27
• Study First Posted: 2021-10-08
• Study Start: 2022-02-03
• Primary Completion: 2022-12-12
• Study Completion: 2022-12-12
• Results First Submitted: 2024-06-17
• Status Verified: 2025-02
• Results First Submitted QC: 2025-03-12
• Last Update Submitted: 2025-03-12
• Results First Posted: 2025-03-18
• Last Update Posted: 2025-03-18

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 86

Inclusion Criteria

Not provided

Exclusion Criteria

1. 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).
2. Any clinically significant electrocardiogram (ECG) abnormalities at screening.
3. 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.
4. Inadequate renal function defined as serum creatinine >1.5 × the ULN range of each institution and/or estimated glomerular filtration rate (eGFR) <60.
5. Any clinically significant abnormalities in clinical laboratory assessments as assessed by the Investigator.
6. 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.
7. Unable to complete neuropsychological testing.
8. Diagnosis of Bipolar I, Bipolar II disorder or Schizophrenia.
9. History of suicidal behaviors including ideation.
10. Current treatment with doses of benzodiazepines that are outside the FDA-approved prescriber's information.
11. Already on treatment with either telmisartan or verapamil or both.
12. Documented prior drug allergy to either telmisartan or verapamil.
13. Documented contraindication to taking telmisartan or verapamil: (eg, Duchenne's muscular dystrophy, myasthenia gravis).
14. Documented moderate to severe substance abuse within the last 6 months (recreational cannabis use is allowed).
15. Pregnant or breastfeeding.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Placebo Treatment	Placebo	Approximately 40 patients will receive a matched placebo.
Active Treatment (HB-01)	HB-01	Approximately 40 patients will receive HB-01 active study drug.

Primary Outcome Measures

Name	Time	Method
Incidence of Treatment-Emergent Adverse Events	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 Clinical Global Impression-Severity Scale (CGI-S)	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".
Change in Panic Disorder Symptom Severity Scale (PDSS)	Up to 12 weeks	Percentage of patients who achieved panic free status after 12 weeks"

Secondary Outcome Measures

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

Trial Locations

Locations (8)

Richmond Behavioral Associates; 🇺🇸 Staten Island, New York, United States

Collaborative Neuroscience Research; 🇺🇸 Garden Grove, California, United States

Uptown Research Institute; 🇺🇸 Chicago, Illinois, United States

Lumos Psychiatric Services; 🇺🇸 San Jose, California, United States

Hassman Research Institute; 🇺🇸 Berlin, New Jersey, United States

Institute of Living; 🇺🇸 Hartford, Connecticut, United States

SPRI Clinical Trials; 🇺🇸 Brooklyn, New York, United States

CNS Healthcare; 🇺🇸 Memphis, Tennessee, United States