Actively Recruiting
Efficacy and Safety of HB-1 for Panic Disorder: A Multicenter, Randomized, Double-Blind, Placebo-Controlled Trial
Led by HB BioTech, LLC · Updated on 2026-05-28
240
Participants Needed
23
Research Sites
4 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating the safety and efficacy of HB-1 compared to placebo and two other monotherapies in adults aged 18 to 65 years who have Panic Disorder. This multicenter, randomized, double-blind, placebo-controlled trial aims to enroll approximately 240 to 600 participants diagnosed according to DSM-V criteria. The study includes both males and females, with or without certain coexisting conditions, to better understand treatment options for Panic Disorder. Participants will be randomly assigned to one of four groups: HB-1 once daily, telmisartan once daily, verapamil once daily, or placebo once daily. HB-1 is a dual active pharmaceutical ingredient tablet, while telmisartan and verapamil are single active ingredient tablets. The treatment period lasts 12 weeks, followed by a safety follow-up visit one week after the last dose. During the study, participants will be monitored regularly for unexpected panic attacks and treatment-emergent adverse events at multiple time points from screening through week 13. Additional assessments include changes in clinical global impression of severity and panic disorder symptom severity at baseline and weeks 4, 8, and 12. Participants must remain on stable psychiatric medications and comply with scheduled visits and study procedures throughout the trial.
CONDITIONS
Brief 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
- Meets DSM-V criteria for Panic Disorder diagnosis
- 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 remain on current doses of psychiatric medications during the trial
- Able and willing to safely stop or avoid certain medications and substances before and during the study
- Willing to take HB-1, telmisartan, verapamil, or placebo
- Able to provide informed consent and comply with study procedures
- Female participants must be surgically sterile, postmenopausal, or use two forms of birth control during and 4 months after treatment; males must be sterile or use reliable birth control
- Female participants of childbearing potential must have a negative pregnancy test within 7 days before dosing
You will not qualify if you...
- Any disease, condition, or treatment posing unacceptable risk or interfering with the study
- Current use of benzodiazepines
- Severe agoraphobia or severe generalized anxiety
- Recent history of suicide attempt or hospitalization for depression
- Diagnosis of substance use disorder, OCD, bipolar disorders, schizoaffective or other psychotic disorders
- Severe uncontrolled cardiac disease within 6 months
- Significant ECG abnormalities at screening
- Inadequate liver or kidney function
- Significant laboratory abnormalities
- Conditions interfering with study conduct or interpretation
- Unable to complete neuropsychological testing
- Current treatment with telmisartan or verapamil
- History of severe allergic reaction to telmisartan or verapamil
- Contraindications to telmisartan or verapamil
- Pregnant or breastfeeding
- Participation in another clinical trial within the last 3 months
- Evidence of substance exposure interfering with HB-1 testing as determined by investigator
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - 12 weeks
Participants receive study treatment with HB-1, telmisartan, verapamil, or placebo once daily for panic disorder.
Weekly visits for up to 12 weeks
Duration - 1 week
Participants complete a safety follow-up visit one week after their last dose of study treatment.
1 visit (in-person)
Trial Site Locations
Total: 23 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
Novatrials
Charlestown, New South Wales, Australia, 2290
Actively Recruiting
4
East Sydney Doctors
Darlinghurst, New South Wales, Australia, 2010
Actively Recruiting
5
Momentum Clinical Research Darlinghurst
Darlinghurst, New South Wales, Australia, 2010
Actively Recruiting
6
Paratus Clinical Research Central Coast
Kanwal, New South Wales, Australia, 2259
Withdrawn
7
Canopy Clinical Sutherland
Miranda, New South Wales, Australia, 2228
Completed
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
Withdrawn
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
Actively Recruiting
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
Clinical Trials Institute
Torquay, Victoria, Australia, 3228
Actively Recruiting
23
Clinitrials
West Perth, Western Australia, Australia, 6005
Actively Recruiting
Research Team
K
Karen Smith
A
Alon Seifan
How is the study designed?
Study Type
INTERVENTIONAL
Masking
TRIPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
4
Similar Trials
Frequently Asked Questions
Have more questions? Get in touch with our team for quick support
Not the Right Trial for You?
Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.
Already have an account? Log in here