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

NCT07499440 | Recruiting Phase 2 DMC FDA Drug

• 1 other identifier: HB-PTSD-001
• Study Type: interventional
• Target: 200
• Locations: 1 country
• Sites: 15

Brief 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).

Conditions

PTSD; Mental Illness

Outcome Measures

Primary Outcomes (1)

• 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.

  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 Outcomes (5)

• 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.

  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.

  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.

  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.

  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.

  Baseline, Week 4, Week 8 and Week 12.

Study Arms (2)

HB-1

EXPERIMENTAL

HB-1 will be supplied as a dual active pharmaceutical ingredient tablet.

Drug: HB-1

Placebo

PLACEBO COMPARATOR

Matched Placebo will be supplied as a tablet.

Drug: Placebo

Interventions

HB-1 DRUG

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.

HB-1

Placebo DRUG

Matching Placebo will be dispensed to analogous subjects in Placebo group.

Placebo

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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).

Sponsors & Collaborators

• HB BioTech, LLC: lead

Study Sites (15)

Paratus Clinical Research Canberra

Bruce, Australian Capital Territory, 2617, Australia

RECRUITING

Novatrials

Charlestown, New South Wales, 2290, Australia

RECRUITING

East Sydney Doctors

Darlinghurst, New South Wales, 2010, Australia

RECRUITING

Innovate Clinical Research

Waitara, New South Wales, 2077, Australia

RECRUITING

WSLHD Mental Health Services, Westmead Hospital

Westmead, New South Wales, 2145, Australia

NOT YET RECRUITING

Paratus Clinical Research Brisbane

Herston, Queensland, 4006, Australia

NOT YET RECRUITING

Mackay Hospital and Health Service

Mackay, Queensland, 4740, Australia

NOT YET RECRUITING

University of the Sunshine Coast Clinical Trials, Morayfield

Morayfield, Queensland, 4506, Australia

NOT YET RECRUITING

University of the Sunshine Coast Clinical Trials, Sippy Downs

Sippy Downs, Queensland, 4556, Australia

NOT YET RECRUITING

South Australian Health and Medical Research Institute

Adelaide, South Australia, 5000, Australia

RECRUITING

NeuroCentrix

Carlton, Victoria, 3053, Australia

NOT YET RECRUITING

Peninsula Therapeutic and Research Group

Frankston, Victoria, 3199, Australia

RECRUITING

Monash Alfred Psychiatry Research Centre

Melbourne, Victoria, 3004, Australia

NOT YET RECRUITING

Ramsay Clinic Albert Road

Melbourne, Victoria, 3004, Australia

RECRUITING

Paratus Clinical Research Melbourne

Northcote, Victoria, 3070, Australia

RECRUITING

MeSH Terms

Conditions

Stress Disorders, Post-Traumatic; Mental Disorders

Condition Hierarchy (Ancestors)

Stress Disorders, Traumatic; Trauma and Stressor Related Disorders

Central Study Contacts

Karen Smith

CONTACT

+1-650-722-9813; karen.smith@hbbio.com

Alon Seifan

CONTACT

alon.seifan@hbbio.com

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Masking Details: An unblinded pharmacist will be utilized to assign bottles to each patient using an interactive voice response system (IVRS) central randomization system. Study treatment or placebo will be dispensed to patients in blinded bottles.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: A sample size of 200 patients (up to a maximum of 500) is planned for the study to be randomized in a 1:1 ratio of active to placebo control.

Study Record Dates

• First Submitted: March 24, 2026
• First Posted: March 30, 2026
• Study Start: June 1, 2026
• Primary Completion (Estimated): September 1, 2027
• Study Completion (Estimated): October 1, 2027
• Last Updated: June 4, 2026

Record last verified: 2026-06

Data Sharing

• IPD Sharing: Will not share

Locations

AU (15)