NCT05071430

Safety and Efficacy of HB-1 for Panic Disorder

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

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 86 (actual)
• Sponsor: Honeybrains Biotech LLC · Industry
• Sex: All
• Age: 18 Years – 60 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Panic Disorder

Interventions

Type	Name	Description
DRUG	HB-01	HB-1 will be supplied as a dual active pharmaceutical ingredient tablet.
DRUG	Placebo	HB-1 matched placebo

Timeline

• Start date: 2022-02-03
• Primary completion: 2022-12-12
• Completion: 2022-12-12
• First posted: 2021-10-08
• Last updated: 2025-03-18
• Results posted: 2025-03-18

Locations

10 sites across 1 country: United States

Regulatory

• FDA-regulated drug study