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Safety and Efficacy of HB-1 for Post-Traumatic Stress Disorder
Sponsor: Honeybrains Biotech LLC
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
Conditions
Interventions
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.
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