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

June 3, 2026 updated by: HB BioTech, LLC

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

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).

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Estimated)

200

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • Australia
    • Australian Capital Territory
      • Bruce, Australian Capital Territory, Australia, 2617
        • Recruiting
        • Paratus Clinical Research Canberra
        • Contact:
        • Principal Investigator:
          • Dr Amber Leah
    • New South Wales
      • Charlestown, New South Wales, Australia, 2290
        • Recruiting
        • Novatrials
        • Contact:
        • Principal Investigator:
          • Dr Vidushi Khatri
      • Darlinghurst, New South Wales, Australia, 2010
        • Recruiting
        • East Sydney Doctors
        • Principal Investigator:
          • Dr David Baker
        • Contact:
      • Waitara, New South Wales, Australia, 2077
        • Recruiting
        • Innovate Clinical Research
        • Principal Investigator:
          • Rachel Graham
        • Contact:
      • Westmead, New South Wales, Australia, 2145
        • Not yet recruiting
        • WSLHD Mental Health Services, Westmead Hospital
        • Contact:
        • Principal Investigator:
          • Prof. Valsios Brakoulias
    • Queensland
      • Herston, Queensland, Australia, 4006
      • Mackay, Queensland, Australia, 4740
      • Morayfield, Queensland, Australia, 4506
        • Not yet recruiting
        • University of the Sunshine Coast Clinical Trials, Morayfield
        • Contact:
        • Principal Investigator:
          • Chris Moller
      • Sippy Downs, Queensland, Australia, 4556
        • Not yet recruiting
        • University of The Sunshine Coast Clinical Trials, Sippy Downs
        • Contact:
        • Contact:
        • Principal Investigator:
          • Amanda Thomson
    • South Australia
      • Adelaide, South Australia, Australia, 5000
        • Recruiting
        • South Australian Health and Medical Research Institute
        • Contact:
        • Contact:
        • Principal Investigator:
          • Frances Adams
    • Victoria
      • Carlton, Victoria, Australia, 3053
      • Frankston, Victoria, Australia, 3199
        • Recruiting
        • Peninsula Therapeutic and Research Group
        • Contact:
        • Principal Investigator:
          • Jennifer Grunfeld
      • Melbourne, Victoria, Australia, 3004
        • Recruiting
        • Ramsay Clinic Albert Road
        • Contact:
        • Principal Investigator:
          • Malcolm Hopwood
      • Melbourne, Victoria, Australia, 3004
        • Not yet recruiting
        • Monash Alfred Psychiatry Research Centre
        • Contact:
        • Principal Investigator:
          • Dr Rebecca Ho
      • Northcote, Victoria, Australia, 3070
        • Recruiting
        • Paratus Clinical Research Melbourne
        • Contact:
        • Contact:
          • A/Prof Bernadette Fitzgibbon
        • Principal Investigator:
          • Dr Kianoosh Noori Samie

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Male or female aged 18 to 65 years old, inclusive, at the time of informed consent.
  • Meets DSM-V Criteria for PTSD.
  • Minimum CAPS-5 score of at least 26 (based on the optimal diagnostic correspondence in the definitive CAPS-5 psychometric validation study).
  • Clinically stable on current medication and/or therapy regimen for at least 2 months, as determined by Investigator.
  • Willing to remain on current doses of other psychiatric medications throughout the length of the trial.
  • Willing and able to safely stop any medications that are contraindicated to be taken together with HB-1, as determined by Investigator.
  • Fluent in English.
  • Willing to take HB-1.
  • Willing and able to provide informed consent indicating an understanding of the requirements of the study and a willingness to comply with scheduled visits and all study procedures.
  • Female subjects must be surgically sterile (or have a monogamous partner who is surgically sterile) or be at least 2 years postmenopausal or agree to commit to use acceptable forms of birth control (defined as the use of an intrauterine device, a barrier method with spermicide, condoms, any form of hormonal contraceptives, or abstinence) for the duration of the study. Investigator shall use discretion and familiarity with subject's preferred and usual lifestyle to understand if reporting of abstinence may be trusted to achieve 100% effectiveness. Male subjects must be sterile (biologically or surgically) or commit to the use of a reliable method of birth control (condoms with spermicide) for the duration of the study and for 4 months following the last dose of study treatment. Individuals who are involved exclusively in same-sex relationships are exempt from the birth control requirements but must agree to abide by the recommendations if they do engage in a heterosexual relationship.
  • Female subjects who are women of childbearing potential (WOCBP) must have a negative pregnancy test at Screening within 7 days of dosing with study treatment.

Exclusion Criteria:

  • Any ongoing concomitant disease, condition, or treatment that could interfere with the conduct of the study, or that would, in the opinion of the Investigator or Sponsor, pose an unacceptable risk to the participant in the study or interfere with the interpretation of study data.
  • Ongoing treatment with benzodiazepines (e.g. alprazolam, diazepam, clonazepam, lorazepam) or opiates (e.g., codeine, morphine) as assessed by clinical interview and urine toxicology testing.
  • Ongoing treatment with any medication that has a clinically significant drug-drug interaction with either telmisartan or verapamil, per the verapamil SR and telmisartan FDA labels and per standard drug interaction compendia. These include but are not limited to: Inhibitors or inducers of cytochrome P450 (CYP)3A4 (including certain β-hydroxy β-methylglutaryl-CoA [HMG-CoA] reductase inhibitors), Ivabradine, Antihypertensive Agents (including Beta Blockers), Antiarrhythmic Agents, Lithium, Carbamazepine, Rifampin, Phenobarbital, cyclosporin, theophylline, Inhalation Anesthetics, Neuromuscular Blocking Agents, Telithromycin, mTOR inhibitors as well as strong P-glycoprotein inhibitors (e.g., macrolides, ritonavir, itraconazole, ketoconazole, cyclosporin, ritonavir, and ivermectin).
  • Diagnosis of Severe Substance Use Disorder, Obsessive-Compulsive Disorder (OCD), Bipolar I, Bipolar II disorder, or Psychotic disorder (per SCID-V) or Borderline Personality Disorder (per Short-Bord).
  • Active suicidal ideation and behavior (Columbia-Suicide Severity Rating Scale [C-SSRS] score ≥ 4 at Screening, or who has made a serious suicide attempt in the last 3 months).
  • Severe uncontrolled cardiac disease within 6 months of Screening, including but not limited to: severe uncontrolled hypertension, hypotension (below 90/60 mmHg); unstable angina; myocardial infarction (MI) or cerebrovascular accident (CVA).
  • Any clinically significant electrocardiogram (ECG) abnormalities at screening.
  • Inadequate hepatic function defined as total bilirubin > 1.5 × the upper limit of normal (ULN) ranges of each institution, aspartate aminotransferase (AST) and alanine aminotransferase (ALT) > 3 × the ULN range of each institution.
  • Inadequate renal function defined as serum creatinine > 1.5 × the ULN range of each institution and/or estimated glomerular filtration rate (eGFR) < 60 mL/min.
  • Any clinically significant abnormalities in clinical laboratory assessments as assessed by the Investigator.
  • Already on treatment with either telmisartan or verapamil or both.
  • Documented contraindication to taking telmisartan or verapamil: (eg, prior drug allergy, Duchenne's muscular dystrophy, myasthenia gravis).
  • Pregnant or breastfeeding.
  • Participation in another current clinical trial or prior trial within the last three months.
  • Urinalysis evidence of exposure to substances that may interfere with HB-1 testing (per investigator discretion).

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: HB-1
HB-1 will be supplied as a dual active pharmaceutical ingredient tablet.
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.
Placebo Comparator: Placebo
Matched Placebo will be supplied as a tablet.
Drug: Placebo
Matching Placebo will be dispensed to analogous subjects in Placebo group.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
To measure the efficacy of HB-1 on clinician-rated symptoms of Post-Traumatic Stress Disorder in male and female adults (age 18 to 65 years) with Post-Traumatic Stress Disorder.
Time Frame: Baseline, Week 4, Week 8 and Week 12.

Change from Baseline to Week 12 in Clinician-Administered PTSD Scale for Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (DSM-5) (CAPS-5), Past Month Version.

The 5 point Clinician-Administered PTSD Scale-5 symptom severity scale is used for all Post-Traumatic Stress Disorder symptoms.

The scale has a minimum score of zero (Absent), One (Mild), Two (Moderate), Three (Severe) and Four (Extreme) (the maximum score is 4). Higher score indicates a worse outcome.
Baseline, Week 4, Week 8 and Week 12.

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
To measure the efficacy of HB-1 on clinical global impression (CGI) and other clinically accepted, Post-Traumatic Stress Disorder (PTSD)-related outcome measures in male and female adults (age 18 to 65 years) with PTSD.
Time Frame: From enrolment to the end of treatment at 12 weeks. Baseline, Week 4, Week 8 and Week 12.

Change from Baseline to Week 12 in Clinical Global Impression-Severity Scale (CGI-S).

The 8 point Clinical Global Impression-Severity Scale (CGI-S) has a minimum score of Zero (Not assessed), One (Normal, not ill at all), Two (Borderline ill), Three (Mildly ill), Four (Moderately ill), Five (Markedly ill), Six (Severely ill) and Seven (Among the most extremely ill patients) (the maximum score is 7). Higher score indicates a worse outcome.
From enrolment to the end of treatment at 12 weeks. Baseline, Week 4, Week 8 and Week 12.
To measure the efficacy of HB-1 on clinically accepted Perceived Stress Scale (PSS), Post-Traumatic Stress Disorder (PTSD)-related outcome measures in male and female adults (age 18 to 65 years) with PTSD.
Time Frame: Baseline, Week 4, Week 8 and Week 12.
Change from baseline to Week 12 in Perceived Stress Scale (PSS). The 5 point Perceived Stress Scale (PSS) has a minimum score of Zero (Never), One (Almost never), Two (Sometimes), Three (Fairly often) and Four (Very often) (the maximum score is 4). Higher score indicates a worse outcome.
Baseline, Week 4, Week 8 and Week 12.
To measure the efficacy of HB-1 on clinically accepted Brief Symptom Inventory (BSI), PTSD-related outcome measures in male and female adults (age 18 to 65 years) with PTSD.
Time Frame: Baseline, Week 4, Week 8 and Week 12.
Change from baseline to Week 12 in Brief Symptom Inventory (BSI). The scale has a minimum score of Zero (Not at all), plus other scores including One (A little bit), Two (Moderately), Three (Quite a bit) and 4 (Extremely) (the maximum score is 4). Higher score indicates a worse outcome.
Baseline, Week 4, Week 8 and Week 12.
To measure the efficacy of HB-1 on clinically accepted Patient Global Impression-Severity Scale, Post-Traumatic Stress Disorder (PTSD)-related outcome measures in male and female adults (age 18 to 65 years) with PTSD.
Time Frame: Baseline, Week 4, Week 8 and Week 12.
Change from baseline to Week 12 in Patient Global Impression-Severity Scale (PGI-S). Scale ranges from None, Mild, Moderate, Severe and Very Severe.
Baseline, Week 4, Week 8 and Week 12.
To measure the efficacy of HB-1 on clinically accepted Sheehan Disability Scale (SDS), PTSD-related outcome measures in male and female adults (age 18 to 65 years) with PTSD.
Time Frame: Baseline, Week 4, Week 8 and Week 12.
Change from baseline to Week 12 in Sheehan Disability Scale (SDS). The 10 point scale has a minimum score of Zero (Not at all) and a maximum score of Ten (Extremely). Higher score indicates a worse outcome.
Baseline, Week 4, Week 8 and Week 12.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

HB BioTech, LLC

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

June 1, 2026

Primary Completion (Estimated)

September 1, 2027

Study Completion (Estimated)

October 1, 2027

Study Registration Dates

First Submitted

March 24, 2026

First Submitted That Met QC Criteria

March 24, 2026

First Posted (Actual)

March 30, 2026

Study Record Updates

Last Update Posted (Actual)

June 4, 2026

Last Update Submitted That Met QC Criteria

June 3, 2026

Last Verified

June 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • HB-PTSD-001

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on PTSD

Clinical Trials on HB-1

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Suriname

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe