NCT07499440

Safety and Efficacy of HB-1 for Post-Traumatic Stress Disorder

Safety and Efficacy of HB-1 for PTSD: A Multi-center, Randomized, Double-Blind, Placebo-Controlled Study

• Status: Not Yet Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 200 (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 in male and female adult patients aged 18 to 65 years, inclusive, with Post-Traumatic Stress Disorder (PTSD).

Detailed description

This is a flexible-dose, multi-centre, double-blind, placebo-controlled trial for adults with Post Traumatic Stress Disorder (PTSD). This study will enrol approximately 200 (up to 500) adults patients diagnosed with PTSD, without severe neuropsychiatric or medical co-morbidities. Participants will be recruited from multiple sites in Australia and/or the United States. Patients will be treated for 12 weeks followed by a safety follow up visit one week after their last dose of study treatment. Safety will be assessed by monitoring of treatment emergent adverse events (TEAEs), vital signs, questionnaires, ECG and clinical labs.

Conditions

• PTSD
• Mental Illness

Interventions

Type	Name	Description
DRUG	HB-1	HB-1 will be supplied as a dual active pharmaceutical ingredient tablet. The two HB-1 doses for this study include 64/192 and 86/258 telmisartan/verapamil extended release, using unique bi-layer tablets. All subjects randomized to receive HB-1 will begin with the 64/192mg dose taken as one tablet once per day. At each monthly visit, treatment tolerance and response will be adjudicated using objective, dose-escalation criteria. At both Week 4 and Week 8, all subjects will be evaluated for dose escalation. Subjects who are demonstrating a reduction of 50% or more in CAPS-5 total score will remain in treatment with HB-1 (or Placebo) at same dose. Subjects with less than a 50% reduction in CAPS-5, who have experienced no treatment-emergent Grade 3 or higher adverse event related to study drug since the prior visit, will be dose-escalated to the 86/258mg telmisartan/verapamil extended dose. After escalation, subjects will remain on higher dose throughout the remainder of the study.
DRUG	Placebo	Matching Placebo will be dispensed to analogous subjects in Placebo group.

Timeline

• Start date: 2026-04-01
• Primary completion: 2027-09-01
• Completion: 2027-10-01
• First posted: 2026-03-30
• Last updated: 2026-04-06

Locations

12 sites across 1 country: Australia

Regulatory

• FDA-regulated drug study