Clinical Trial of 2-HOBA in Pulmonary Arterial Hypertension

Sponsor
Vanderbilt University Medical Center
Study ID
NCT06176118
Phase
PHASE2
Status
Not Yet Recruiting

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Conditions

  • Pulmonary Arterial Hypertension

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • 2-HOBA — DIETARY_SUPPLEMENT
    2-HOBA supplement take three times daily for 12-weeks

Study Details

Based on existing literature and clinical trials, 2- hydroxbenzylamine (2-HOBA) has clear impact on mechanisms that much of the international field of pulmonary hypertension (PH) research agrees are central to disease progression. The investigator's preliminary data and Phase I studies demonstrate not only a clear positive impact on reducing pulmonary vascular resistances in Group I and II PH, and both cytokine and molecular biomarkers of disease, but also indicated the potential for a substantial positive effect on heart function under load stress. In this Phase II project, investigators will test the safety and efficacy of 2-HOBA in PH patients, improving the function of the right ventricle under stress in a large animal model, and effectiveness in the context of standard-of-care in mouse models and large animals, to establish the remaining data needed to proceed to commercialization.

Key Dates

First listed
Dec 19, 2023
Start date
Sep 1, 2026
Status verified
Jun 2026
Primary completion
Dec 31, 2027
Completion
Dec 31, 2027

Study Design

Enrollment
12 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Unblinded Intervention
    There is no control group in this study. Only intervention group due to phase of trial and study intentions.

Primary Outcome Measure

Change in acetylated SOD2 and LCAD in plasma [ Time Frame: baseline and 12-weeks ]

Central Contacts

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