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NOT YET RECRUITING
NCT07499440
PHASE2

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

Sponsor: Honeybrains Biotech LLC

View on ClinicalTrials.gov

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).

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

Key Details

Gender

All

Age Range

18 Years - 65 Years

Study Type

INTERVENTIONAL

Enrollment

200

Start Date

2026-04

Completion Date

2027-10

Last Updated

2026-04-06

Healthy Volunteers

No

Interventions

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.

Locations (12)

Paratus Clinical Research Canberra

Bruce, Australian Capital Territory, Australia

Novatrials

Charlestown, New South Wales, Australia

Innovate Clinical Research

Waitara, New South Wales, Australia

Paratus Clinical Research Brisbane

Herston, Queensland, Australia

Mackay Hospital and Health Service

Mackay, Queensland, Australia

University of the Sunshine Coast Clinical Trials, Morayfield

Morayfield, Queensland, Australia

University of the Sunshine Coast Clinical Trials, Sippy Downs

Sippy Downs, Queensland, Australia

South Australian Health and Medical Research Institute

Adelaide, South Australia, Australia

NeuroCentrix

Carlton, Victoria, Australia

Peninsula Therapeutic and Research Group

Frankston, Victoria, Australia

Ramsay Clinic Albert Road

Melbourne, Victoria, Australia

Paratus Clinical Research Melbourne

Northcote, Victoria, Australia