NCT06483789

Efficacy and Safety of HB-1 for Panic Disorder

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

• Status: Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 240 (estimated)
• Sponsor: Honeybrains Biotech LLC · Industry
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this study is to determine the safety and efficacy of HB-1, versus placebo and two monotherapies, in male and female adult patients aged 18 to 65 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 240 (up to 600) adult patients who meet the diagnosis of panic disorder. Patients will be treated for 12 weeks followed by a safety follow up visit one week after their last dose of study treatment.

Conditions

• Panic Disorder
• Mental Illness

Interventions

Type	Name	Description
DRUG	HB-1	HB-1 will be supplied as a dual active pharmaceutical ingredient tablet.
DRUG	Telmisartan Only Product in Oral Dose Form	Telmisartan will be supplied as a single active pharmaceutical ingredient tablet.
DRUG	Verapamil Only Product in Oral Dose Form	Verapamil will be supplied as a single active pharmaceutical ingredient tablet.
DRUG	Placebo	Matched Placebo will be supplied as a tablet.

Timeline

• Start date: 2024-10-29
• Primary completion: 2027-01-01
• Completion: 2027-02-01
• First posted: 2024-07-03
• Last updated: 2025-12-10

Locations

22 sites across 1 country: Australia

Regulatory

• FDA-regulated drug study