NCT06774040

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

A Phase IIa Open Label, Dose-Finding, Clinical Trial to Evaluate Safety, Tolerability and Preliminary Efficacy of Etrinabdione in Patients With Peripheral Arterial Disease (PAD)

• Status: Not Yet Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 30 (estimated)
• Sponsor: VivaCell Biotechnology España · Industry
• Sex: All
• Age: 50 Years – 85 Years
• Healthy volunteers: Not accepted

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.

Detailed description

This is a single center, open-label Phase IIa clinical study. The study will be conducted with 2 treatment arms 25 mg BID and 50 mg BID. The study consists of a Screening Period, a Treatment Period, and a Follow-up Period. Total duration 14 months. Subjects who meet the inclusion criteria and do not meet the exclusion criteria at screening will start with the lower dose (25 mg BID). 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.

Conditions

• Peripheral Arterial Disease

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2026-01-01
• Primary completion: 2027-03-01
• Completion: 2027-05-01
• First posted: 2025-01-14
• Last updated: 2025-09-17

Locations

1 site across 1 country: Spain