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

NCT07499440 · Status: NOT_YET_RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 200

Last updated 2026-04-06

No results posted yet for this study

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).

Conditions

  • PTSD
  • Mental Illness

Interventions

DRUG

HB-1

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.

DRUG

Placebo

Matching Placebo will be dispensed to analogous subjects in Placebo group.

Sponsors & Collaborators

  • Honeybrains Biotech LLC

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-04-30
Primary Completion
2027-09-30
Completion
2027-10-31
FDA Drug
Yes

Countries

  • Australia

Study Locations

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Drugs
Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07499440 on ClinicalTrials.gov