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

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.

Timeline

Start

2026-01-01

Primary completion

2027-03

Completion

2027-05

Publications

• Background Garcia-Martin A, Prados ME, Lastres-Cubillo I, Ponce-Diaz FJ, Cerero L, Garrido-Rodriguez M, Navarrete C, Pineda R, Rodriguez AB, Munoz I, Moya J, Medeot A, Moreno JA, Chacon A, Garcia-Revillo J, Munoz E. Etrinabdione (VCE-004.8), a B55alpha activator, promotes angiogenesis and arteriogenesis in critical limb ischemia. J Transl Med. 2024 Nov 6;22(1):1003. doi: 10.1186/s12967-024-05748-w.

Drugs

Indications