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

NCT06774040 | Not Yet Recruiting Phase 2

• 1 other identifier: Etrinabdione-PAD02
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

Claudication; Arterial Occlusive Disease; Peripheral Artery Disease; Vascular Disease; Peripheral Vascular Disease; Chronic Limb Threatening Ischemia; Critical Limb Ischemia

Outcome Measures

Primary Outcomes (1)

• Incidence and severity of Treatment Emergent Adverse Events (TEAEs)

  This safety outcome combines the measure of the number of subjects experiencing adverse events (AEs), the nature and severity of those AEs and their relationship to the study treatments.

  13 months

Secondary Outcomes (6)

• Vascularization

  Baseline, 6 and 12 months

• Absolute claudication time

  Baseline, 3, 6 and 12 months

• Hemodynamic

  Baseline, 3, 6 and 12 months

• Stenosis

  Baseline, 3, 6 and 12 months

• Disease specific quality of life questionnaire (VascuQoL-6)

  Baseline, 3, 6 and 12 months

Other Outcomes (5)

• Pharmacokinetic profile of Etrinabdione in terms of maximum observed plasma concentration (Cmax).

  pre-dose and 3 hours post dose) at Day 1 and months 1, 3, 6, 12, and 13 months.

• Pharmacokinetic profile of Etrinabdione in terms of time to peak drug concentration (Tmax).

  pre-dose and 3 hours post dose) at Day 1 and months 1, 3, 6, 12, and 13 months.

• Pharmacokinetic profile of Etrinabdione in terms of area under the plasma concentration-time curve (AUC).

  pre-dose and 3 hours post dose) at Day 1 and months 1, 3, 6, 12, and 13 months.

Study Arms (2)

Low dose

EXPERIMENTAL

25 mg BID

Drug: Etribnabdione 25 mg BID

High dose

EXPERIMENTAL

50 mg BID

Drug: Etribnabdione 50 mg BID

Interventions

Etribnabdione 25 mg BID DRUG

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.

Low dose

Etribnabdione 50 mg BID DRUG

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

High dose

Eligibility Criteria

• Age: 50 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Willing and able to provide informed consent and capable of understanding and complying with the protocol;
• Subjects classified as critical limb ischemia (CLI) Rutherford Category 2 or 3 (moderate or severe) claudication;
• Diabetes mellitus type 2 with HbA1c \< 9%;
• In case of treatment for PAD, the subject is controlled on medical therapy indicated for CLI;
• A female patient is eligible to participate if she is not pregnant, not breastfeeding, and agrees to use a highly effective method of contraception;
• A male patient with a female partner of childbearing potential is eligible if he agrees to use acceptable method of contraception.

You may not qualify if:

• Planned surgical or endovascular revascularization on the index leg within the next 12 months;
• Failed surgical or endovascular revascularization on the index leg within 10 days prior to screening;
• Amputation at or above the talus on the index leg;
• Planned major amputation within the first month after screening;
• On the index leg, use of concomitant wound treatments not currently approved for ischemic wound-healing within 30 days prior to screening or plans to initiate new treatments to the index leg during the trial;
• Uncontrolled or untreated proliferative retinopathy;
• Blood clotting disorder not caused by medication;
• Severe hypertension according to the Joint National Committee on Prevention, Detection, Evaluation, and Treatment of High Blood Pressure;
• Evidence of moderate to severe hepatocellular dysfunction;
• Positive test for human immunodeficiency virus 1 (HIV 1), HIV 2, hepatitis B virus (HBV), hepatitis C virus (HCV) or Treponema Pallidum;
• Subjects who may not be healthy enough to successfully complete all protocol requirements, or who are not expected to survive more than 12 months, or in whom results may be particularly difficult to assess.

Sponsors & Collaborators

• VivaCell Biotechnology España: lead

Study Sites (1)

Hospital Universitario Reina Sofía

Córdoba, 14014, Spain

Location

Related Publications (1)

• 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.

  PMID: 39506809 BACKGROUND

Related Links

• Company website

MeSH Terms

Conditions

Peripheral Arterial Disease; Intermittent Claudication; Arterial Occlusive Diseases; Vascular Diseases; Peripheral Vascular Diseases; Chronic Limb-Threatening Ischemia

Interventions

BID protein, human

Condition Hierarchy (Ancestors)

Atherosclerosis; Arteriosclerosis; Cardiovascular Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Chronic Disease; Disease Attributes; Pathologic Processes; Ischemia

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SEQUENTIAL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: The trial 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.

Study Record Dates

• First Submitted: December 20, 2024
• First Posted: January 14, 2025
• Study Start: January 1, 2026
• Primary Completion (Estimated): March 1, 2027
• Study Completion (Estimated): May 1, 2027
• Last Updated: September 17, 2025

Record last verified: 2025-09

Locations

ES (1)