Safety and Efficacy of HB-1 for Post-Traumatic Stress Disorder

Sponsor
HB BioTech, LLC
Study ID
NCT07499440
Phase
PHASE2
Status
Recruiting
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Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - 65 Years
Healthy Volunteers
Not accepted

Interventions

  • HB-1 — DRUG
    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.
  • Placebo — DRUG
    Matching Placebo will be dispensed to analogous subjects in Placebo group.

Study Details

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).

Key Dates

First listed
Mar 30, 2026
Start date
Jun 30, 2026
Status verified
Jul 2026
Primary completion
Sep 30, 2027
Completion
Oct 31, 2027

Study Design

Enrollment
200 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: HB-1
    HB-1 will be supplied as a dual active pharmaceutical ingredient tablet.
  • Placebo Comparator: Placebo
    Matched Placebo will be supplied as a tablet.

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. ]

Central Contacts

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