A Phase 2 interventional study of HB-1 and Placebo in PTSD and Mental Illness, sponsored by HB BioTech, LLC. Recruiting at 16 sites in Australia. Open to participants aged 18 Years to 65 Years. Per ClinicalTrials.gov, last updated 2026-09-24.
Sponsored by HB BioTech, LLC · Phase 2, Interventional, and Treatment
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).
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.
2,682 studies on the registry are indexed under Stress Disorders, Post-Traumatic; 601 are open to participants now.
This study's planned enrollment of 200 is above the median of 69 across 2,196 interventional studies indexed under Stress Disorders, Post-Traumatic.
Browse Stress Disorders, Post-Traumatic studies →HB BioTech, LLC is the lead sponsor of 2 studies on the registry; 1 is open to participants now.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
The American Psychiatric Association’s manual of mental health diagnoses. DSM-5 (2013, revised as DSM-5-TR in 2022) replaced DSM-IV, and some studies still name the older edition. “Meets DSM criteria for …” means diagnosed by that edition’s diagnostic criteria, usually by a clinician in an interview.
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Periods have stopped for good: usually no period for 12 months in a row without another medical reason, sometimes confirmed by a blood test (FSH).
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Able to become pregnant: from the first period until menopause, unless permanently unable to through surgery (removal of the womb, or of both ovaries or both fallopian tubes).
Criteria for people of childbearing potential usually ask for a negative pregnancy test and for contraception during the study and for a time after it.
Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.
A recording of the heart’s electrical activity, taken with stickers on the chest, arms and legs. It takes a few minutes and does not hurt.
A yellow substance made when red blood cells are broken down, which the liver clears. A high level can mean a problem with the liver or the bile ducts.
Criteria often allow more for people with Gilbert’s syndrome, a harmless inherited condition that raises bilirubin.
The top of the normal range for a blood test, as set by the laboratory that runs it. Each lab prints its own range next to your result.
“≤ 2.5 × ULN” means the result can be up to two and a half times that top value.
Two enzymes measured in a routine blood test of the liver. Higher levels can mean the liver is under strain or damaged. SGPT and SGOT are older names for ALT and AST.
Criteria usually give a limit as a multiple of the upper limit of normal (ULN), often higher when cancer has spread to the liver.
GFR (glomerular filtration rate) is how much blood the kidneys filter each minute. It is usually estimated from a blood test — eGFR, by formulas such as CKD-EPI or MDRD — and some studies ask for it to be measured directly instead. Usually given in mL/min/1.73 m².
Check the method, the units and the minimum the study states. A value of 90 or above is in the normal-or-high range, but kidney damage can show in other tests too.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
DSM diagnostic criteria
The American Psychiatric Association’s manual of mental health diagnoses. DSM-5 (2013, revised as DSM-5-TR in 2022) replaced DSM-IV, and some studies still name the older edition. “Meets DSM criteria for …” means diagnosed by that edition’s diagnostic criteria, usually by a clinician in an interview.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraindication
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Postmenopausal
Periods have stopped for good: usually no period for 12 months in a row without another medical reason, sometimes confirmed by a blood test (FSH).
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraception
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Childbearing potential
Able to become pregnant: from the first period until menopause, unless permanently unable to through surgery (removal of the womb, or of both ovaries or both fallopian tubes).
Criteria for people of childbearing potential usually ask for a negative pregnancy test and for contraception during the study and for a time after it.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Clinically significant
Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
ECG (electrocardiogram)
A recording of the heart’s electrical activity, taken with stickers on the chest, arms and legs. It takes a few minutes and does not hurt.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Bilirubin
A yellow substance made when red blood cells are broken down, which the liver clears. A high level can mean a problem with the liver or the bile ducts.
Criteria often allow more for people with Gilbert’s syndrome, a harmless inherited condition that raises bilirubin.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
ULN (upper limit of normal)
The top of the normal range for a blood test, as set by the laboratory that runs it. Each lab prints its own range next to your result.
“≤ 2.5 × ULN” means the result can be up to two and a half times that top value.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
ALT and AST (liver enzymes)
Two enzymes measured in a routine blood test of the liver. Higher levels can mean the liver is under strain or damaged. SGPT and SGOT are older names for ALT and AST.
Criteria usually give a limit as a multiple of the upper limit of normal (ULN), often higher when cancer has spread to the liver.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
GFR and eGFR (kidney filtering)
GFR (glomerular filtration rate) is how much blood the kidneys filter each minute. It is usually estimated from a blood test — eGFR, by formulas such as CKD-EPI or MDRD — and some studies ask for it to be measured directly instead. Usually given in mL/min/1.73 m².
Check the method, the units and the minimum the study states. A value of 90 or above is in the normal-or-high range, but kidney damage can show in other tests too.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
HB-1 will be supplied as a dual active pharmaceutical ingredient tablet.
Drug: HB-1
Matched Placebo will be supplied as a tablet.
Drug: Placebo
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.
Matching Placebo will be dispensed to analogous subjects in Placebo group.
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.
Time frame: Baseline, Week 4, Week 8 and Week 12.
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.
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.
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.
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.
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.
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.
Change from baseline to Week 12 in Patient Global Impression-Severity Scale (PGI-S). Scale ranges from None, Mild, Moderate, Severe and Very Severe.
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.
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.
Time frame: Baseline, Week 4, Week 8 and Week 12.
Plan to share: No
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HB BioTech, LLC