PTSDPhase 2NCT07499440
Safety and Efficacy of HB-1 for Post-Traumatic Stress Disorder
A Phase 2 study testing HB-1 in people with PTSD and Mental Illness, run by HB BioTech, LLC at 16 sites in Australia.
Trial 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). Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- PTSD, Mental Illness
- What is being tested?
- HB-1
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 200 participants
- Where
- 16 sitesAustralia
- Study dates
- 3 Jun 2026to Oct 2027
- Phase
- Phase 2
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
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- 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.
Who cannot join
- 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).
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- 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).
Trial locations and contacts
16 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Alon Seifan contact
16 sites in 1 country
Australia16 sites, 16 recruiting
- Recruiting
South Australian Health and Medical Research Institute
Adelaide, South Australia, 5000
Gemma Barker, gemma.barker@sahmri.com.au
Emma Heath, +61 8 8128 4358, emma.heath@sahmri.com
- Recruiting
NeuroCentrix
Carlton, Victoria, 3053
Nicola Valcanis, +61 3 9546 0009, nicola@neurocentrix.com.au
David Barton, david@neurocentrix.com.au
- Recruiting
Novatrials
Charlestown, New South Wales, 2290
Karen Brenan, +61 2 4089 3744, karen@novatrials.com.au
Dr Vidushi Khatri
- Recruiting
East Sydney Doctors
Darlinghurst, New South Wales, 2010
Chloe Williamson, +61 2 9332 2531, trials@eastsydneydoctors.com.au
Dr David Baker
- Recruiting
Paratus Clinical Research Canberra
Deakin, Australian Capital Territory, 2600
Sarojini Pandit, +61 1300 742 326, sarojini.pandit@paratusclinical.com
Dr Amber Leah
- Recruiting
Peninsula Therapeutic and Research Group
Frankston, Victoria, 3199
Xenia Jung, +61 3 9770 1579, xjung@ptrg.com.au
Jennifer Grunfeld
- Recruiting
Paratus Clinical Research Brisbane
Herston, Queensland, 4006
Steve Turner, +61 1300 742 326, steve.turner@paratusclinical.com
Lauren Marshall, lauren.marshall@paratusclinical.com
- Recruiting
Mackay Hospital and Health Service
Mackay, Queensland, 4740
Joshua Paterson, +61 7 4885 6000, Mackay-Clinical-Trials@health.qld.gov.au
Alok Rana
- Recruiting
Monash Alfred Psychiatry Research Centre
Melbourne, Victoria, 3004
Marta Malicka, +61 3 9076 6924, marta.malicka@monash.edu
Dr Rebecca Ho
- Recruiting
Ramsay Clinic Albert Road
Melbourne, Victoria, 3004
Melanie Hurley, +61 3 9279 3569, research.arc@ramsayhealth.com.au
Malcolm Hopwood
- Recruiting
University of the Sunshine Coast Clinical Trials, Morayfield
Morayfield, Queensland, 4506
Alistair Mallard, +61 7 5409 8644, amallard@usc.edu.au
Chris Moller
- Recruiting
Ramsay Clinic New Farm
New Farm, Queensland, 4005
Leticia Goncalves, +61 7 3254 9232, CardosoGoncalvesL@ramsayhealth.com.au
François Windels, WindelsF@ramsayhealth.com.au
- Recruiting
Paratus Clinical Research Melbourne
Northcote, Victoria, 3070
Jesse Alderson, +61 1300 742 326, recruitment@paratusclinical.com
A/Prof Bernadette Fitzgibbon
- Recruiting
University of the Sunshine Coast Clinical Trials, Sippy Downs
Sippy Downs, Queensland, 4556
Ryan Stewart, +61 7 5409 8644, rstewart2@usc.edu.au
+61 7 5409 8644, amallard@usc.edu.au
- Recruiting
Innovate Clinical Research
Waitara, New South Wales, 2077
Regina Cruz, +61 2 9159 3838, rcruz@innovateclinical.com.au
Rachel Graham
- Recruiting
WSLHD Mental Health Services, Westmead Hospital
Westmead, New South Wales, 2145
Taiba Shafaie-Eshaq, +61 2 8890 6688, taiba.shafaieeshaq@health.nsw.gov.au
Prof. Valsios Brakoulias
About this study
Official title: 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).
Read the 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.
- Conditions
- PTSD, Mental Illness
- Being tested
- HB-1, Placebo
- Medical subject headings
- Stress Disorders, Post-Traumatic, Mental Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
HB-1Drug
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.
PlaceboDrug
Matching Placebo will be dispensed to analogous subjects in Placebo group.
| Study group | Role | What they receive |
|---|---|---|
| HB-1 | Experimental | HB-1 will be supplied as a dual active pharmaceutical ingredient tablet. Receives: Drug: HB-1 |
| Placebo | Placebo comparator | Matched Placebo will be supplied as a tablet. Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
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.
Measured: 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.
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.
Measured: 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.
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.
Measured: 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.
Change from baseline to Week 12 in Patient Global Impression-Severity Scale (PGI-S). Scale ranges from None, Mild, Moderate, Severe and Very Severe.
Measured: 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.
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.
Measured: Baseline, Week 4, Week 8 and Week 12.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Mar 2026
- Study start3 Jun 2026
- Primary completionSep 2027 (estimated)
- Study completionOct 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PTSDStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- 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.
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- HB BioTech, LLC
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07499440
- Sponsor's protocol ID
- HB-PTSD-001
- Status last verified
- Sep 2026
- First submitted
- 24 Mar 2026
- Last updated
- 24 Sep 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Safety and Efficacy of HB-1 for PTSD: A Multi-center, Randomized, Double-Blind, Placebo-Controlled Study
- ClinicalTrials.gov ID
- NCT07499440
- Acronym / sponsor ID
- HB-PTSD-001
- Conditions
- PTSD, Mental Illness
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- HB BioTech, LLCIndustry (pharma, biotech, devices)
- Study start
- 3 Jun 2026 (actual)
- Primary completion
- Sep 2027 (estimated)
- Study completion
- Oct 2027 (estimated)
- First posted
- 30 Mar 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
- Model description
- 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.
| Arm | Type | Receives |
|---|---|---|
| HB-1 | Experimental | Drug: HB-1HB-1 will be supplied as a dual active pharmaceutical ingredient tablet. |
| Placebo | Placebo comparator | Drug: PlaceboMatched Placebo will be supplied as a tablet. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- 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.
Key exclusion criteria (15 listed)
- 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).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| HB-1HB-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 | HB-1 |
| PlaceboMatching Placebo will be dispensed to analogous subjects in Placebo group. | Drug | Placebo |
Primary outcome
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.
5 secondary outcomes
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.
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.
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.
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.
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.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Sep 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Alon Seifan contact
16 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing HB-1 in people with PTSD and Mental Illness, run by HB BioTech, LLC at 16 sites in Australia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 11 inclusion and 15 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 24 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 16 sites in Australia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Karen Smith (+1-650-722-9813, karen.smith@hbbio.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Sep 2026.