Actively Recruiting
Efficacy and Safety of HB-1 for Panic Disorder
Led by HB BioTech, LLC · Updated on 2025-12-10
240
Participants Needed
22
Research Sites
117 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
The purpose of this study is to determine the safety and efficacy of HB-1, versus placebo and two monotherapies, in male and female adult patients aged 18 to 65 years, inclusive, with Panic Disorder.
CONDITIONS
Official Title
Efficacy and Safety of HB-1 for Panic Disorder
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Male or female aged 18 to 65 years old, inclusive, at the time of informed consent.
- Meets Diagnostic and Statistical Manual of Mental Disorders 5th Edition (DSM-V) criteria for Panic Disorder.
- At least one full, unexpected panic attack in the week before screening.
- Medically stable on current medication regimen for at least 3 months.
- Willing to keep current doses of other psychiatric medications during the trial.
- Able to safely stop or avoid certain medications and substances prior to the study.
- Willing to take HB-1, telmisartan, verapamil, or placebo.
- Able to provide informed consent and comply with study visits and procedures.
- Female subjects must be surgically sterile, postmenopausal for at least 2 years, or agree to use two forms of birth control during and 4 months after the study.
- Male subjects must be sterile or agree to use reliable birth control during and 4 months after the study.
- Female subjects of childbearing potential must have a negative pregnancy test within 7 days of starting treatment.
You will not qualify if you...
- Any disease, condition, or treatment that may interfere with the study or pose risk.
- Current use of benzodiazepines.
- Severe agoraphobia or severe generalized anxiety.
- History of suicide attempt or recent hospitalization for depression.
- Diagnosis of certain mental disorders including substance use disorder, OCD, bipolar disorder, or psychotic disorders.
- Severe uncontrolled heart disease within 6 months before screening.
- Significant electrocardiogram abnormalities.
- Poor liver or kidney function.
- Other significant clinical laboratory abnormalities.
- Unable to complete neuropsychological testing.
- Already treated with telmisartan or verapamil.
- History of severe allergic reaction or contraindication to telmisartan or verapamil.
- Pregnant or breastfeeding.
- Participation in another clinical trial within the last 3 months.
- Evidence of substance use interfering with HB-1 testing.
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 22 locations
1
Paratus Clinical Research Canberra
Canberra, Australian Capital Territory, Australia, 2617
Actively Recruiting
2
Paratus Clinical Research Western Sydney
Blacktown, New South Wales, Australia, 2148
Actively Recruiting
3
East Sydney Doctors
Darlinghurst, New South Wales, Australia, 2010
Actively Recruiting
4
Momentum Clinical Research Darlinghurst
Darlinghurst, New South Wales, Australia, 2010
Actively Recruiting
5
Paratus Clinical Research Central Coast
Kanwal, New South Wales, Australia, 2259
Actively Recruiting
6
Novatrials
Kotara, New South Wales, Australia, 2289
Actively Recruiting
7
Canopy Clinical Sutherland
Miranda, New South Wales, Australia, 2228
Actively Recruiting
8
Innovate Clinical Research
Waitara, New South Wales, Australia, 2077
Actively Recruiting
9
Westmead Hospital
Westmead, New South Wales, Australia, 2145
Actively Recruiting
10
Canopy Clinical Wollongong
Wollongong, New South Wales, Australia, 2500
Actively Recruiting
11
Paratus Clinical Research Brisbane
Herston, Queensland, Australia, 4006
Actively Recruiting
12
Mackay Hospital and Health Service
Mackay, Queensland, Australia, 4740
Actively Recruiting
13
Gold Coast University Hospital
Southport, Queensland, Australia, 4215
Actively Recruiting
14
South Australian Health and Medical Research Institute
Adelaide, South Australia, Australia, 5000
Actively Recruiting
15
Lyell McEwin Hospital
Elizabeth Vale, South Australia, Australia, 5112
Withdrawn
16
Grampians Health
Ballarat, Victoria, Australia, 3350
Withdrawn
17
NeuroCentrix
Carlton, Victoria, Australia, 3053
Actively Recruiting
18
Peninsula Therapeutic and Research Group
Frankston, Victoria, Australia, 3199
Completed
19
Multidisciplinary Alfred Psychiatry Research Clinic
Melbourne, Victoria, Australia, 3004
Actively Recruiting
20
Ramsay Clinic Albert Road
Melbourne, Victoria, Australia, 3004
Actively Recruiting
21
Paratus Clinical Research Melbourne
Northcote, Victoria, Australia, 3070
Actively Recruiting
22
Clinitrials
Perth, Western Australia, Australia, 6000
Actively Recruiting
Research Team
K
Karen Smith
CONTACT
A
Alon Seifan
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
TRIPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
4
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