HB-1 for PTSD: testing safety and efficacy vs placebo in adults 18-65
Official title: Safety and Efficacy of HB-1 for PTSD: A Multi-center, Randomized, Double-Blind, Placebo-Controlled Study
Run by HB BioTech, LLC · NCT07499440 · Data updated 2026-11-12
This study tests whether HB-1 helps reduce PTSD symptoms in adults aged 18–65 compared with a placebo.
Quick facts
| Phase | Phase 2 |
|---|---|
| Study type | Interventional |
| Ages | 18 Years to 65 Years |
| Sex | All |
| Enrollment | 200 (estimated) |
| Sponsor | HB BioTech, LLC Industry-sponsored |
| Locations | 16 sites (Deakin, Australian Capital Territory and 15 other locations) |
| Status | Recruiting |
| Started | June 3, 2026 |
| Main results expected | September 2027 |
| Study ends | October 2027 |
| Registry record updated | September 24, 2026 |
| Trial ID | NCT07499440 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Adults 18–65 with DSM-5 PTSD, CAPS-5 ≥ 26, stable on other treatments, and able to use HB-1 safely.
✕Probably not a fit
Individuals with major neuropsychiatric or medical comorbidities or contraindications to HB-1 may not benefit.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This is a phase 2, double-blind, placebo-controlled trial to evaluate the safety and effectiveness of HB-1 in adults with PTSD. It uses a flexible-dose design across multiple centers in Australia and the United States and plans to enroll about 200 participants (up to 500). Participants will be treated for 12 weeks and followed for one week after the last dose, with safety monitored through adverse events, vital signs, labs, ECGs, and questionnaires. Eligible participants must have DSM-5 PTSD with a CAPS-5 score of at least 26, be clinically stable on other treatments, and meet language and reproductive criteria.
Why it matters
Potential benefit: If successful, HB-1 could reduce PTSD symptoms and improve functioning for adults with PTSD.
How similar studies have gone: Prior similar early-phase approaches in PTSD have shown signals of safety and potential symptom improvement, but this specific HB-1 approach is being tested in a larger, rigorous trial.
Who can join: the full rules
Show full inclusion / exclusion criteria
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).
Where it's running
-
Paratus Clinical Research Canberra
Deakin, Australian Capital Territory, Australia Recruiting -
Novatrials
Charlestown, New South Wales, Australia Recruiting -
East Sydney Doctors
Darlinghurst, New South Wales, Australia Recruiting -
Innovate Clinical Research
Waitara, New South Wales, Australia Recruiting -
WSLHD Mental Health Services, Westmead Hospital
Westmead, New South Wales, Australia Recruiting -
Paratus Clinical Research Brisbane
Herston, Queensland, Australia Recruiting
Show 10 more locations
-
Mackay Hospital and Health Service
Mackay, Queensland, Australia Recruiting -
University of the Sunshine Coast Clinical Trials, Morayfield
Morayfield, Queensland, Australia Recruiting -
Ramsay Clinic New Farm
New Farm, Queensland, Australia Recruiting -
University of the Sunshine Coast Clinical Trials, Sippy Downs
Sippy Downs, Queensland, Australia Recruiting -
South Australian Health and Medical Research Institute
Adelaide, South Australia, Australia Recruiting -
NeuroCentrix
Carlton, Victoria, Australia Recruiting -
Peninsula Therapeutic and Research Group
Frankston, Victoria, Australia Recruiting -
Monash Alfred Psychiatry Research Centre
Melbourne, Victoria, Australia Recruiting -
Ramsay Clinic Albert Road
Melbourne, Victoria, Australia Recruiting -
Paratus Clinical Research Melbourne
Northcote, Victoria, Australia Recruiting
Study contacts
- Study coordinator: Karen Smith
- Email: karen.smith@hbbio.com
- Phone: +1-650-722-9813
Similar studies
Other studies for the same condition or treatment. Recruiting studies are listed first.
-
Hyperbaric Oxygen Therapy for Veterans With TBI and PCS
This study tests whether 40 HBOT sessions can change blood biomarkers in veterans with traumatic brain injury and persistent symptoms, and whether PTSD affects those biomarker changes.
-
Internet-delivered ACT for youth with PTSD and chronic pain
A small pilot study will test a web-based Acceptance and Commitment Therapy program for teens and young adults with PTSD and chronic pain to see if it helps with symptoms and functioning.
-
Reboxetine plus Ritalin vs Dog-Assisted Therapy for PTSD
This study tests whether a drug combo of reboxetine and methylphenidate works better than dog-assisted therapy for people with PTSD.
-
How people disclose suicidal thoughts and get support in rural eastern Uganda
This study tests how disclosure of suicidal thoughts or severe distress affects social support or harm, and who should be involved in future help.
-
Floatation-REST for frontline workers with post-traumatic stress symptoms
This early pilot tests whether two 60-minute Floatation-REST sessions can be safely tried by frontline healthcare workers and first responders who have post-traumatic stress symptoms, compared to watching a documentary.
-
Short-Term Intensive PTSD Treatment for Military Personnel
This trial tests whether a brief, massed form of CPT and EMDR can quickly reduce PTSD symptoms and related cognitive problems in active-duty military personnel.
How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.