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Evaluation of Safety, Tolerability and Preliminary Efficacy of Etrinabdione in Patients With Peripheral Arterial Disease

NCT06774040 · Status: NOT_YET_RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 30

Last updated 2025-09-17

No results posted yet for this study

Summary

The goal of this clinical trial is to study the safety and tolerability of Etrinabdione in adult patients with peripheral arterial disease. It will also learn about the preliminary efficacy of Etrinabdione. The main questions it aims to answer are:

Has Etrinabdione an acceptable safety/tolerability profile during 12 months?

Do the patients show any improvement in any of the tests included in the protocol for this disease?

Researchers will test first the low dose of Etrinadione. If the product is safe at 3 months, the high dose can start.

Participants will:

Take Etrinabdione twice a day for 12 months. Visit the clinic once every 4 weeks for checkups and tests.

Conditions

  • Peripheral Arterial Disease

Interventions

DRUG

Etribnabdione 25 mg BID

The trial will start with the lower dose. When the 12 patients have been treated for 3 months and the PK and safety data are evaluated by the regulatory authority, the Sponsor and the site investigators, the high dose (50 mg BID) will be released.

DRUG

Etribnabdione 50 mg BID

The treatment will start when the regulatory authority, the sponsor and the site investigators have reviewed the low dose safety and pharmacokinetics data.

Sponsors & Collaborators

  • VivaCell Biotechnology España

    lead INDUSTRY

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
SEQUENTIAL

Eligibility

Min Age
50 Years
Max Age
85 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-01-01
Primary Completion
2027-03-31
Completion
2027-05-31

Countries

  • Spain

Study Locations

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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 NCT06774040 on ClinicalTrials.gov