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

Sponsor
VivaCell Biotechnology España
Study ID
NCT06774040
Phase
PHASE2
Status
Not Yet Recruiting

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Conditions

  • Peripheral Arterial Disease

Eligibility Criteria

Sex
ALL
Age
50 Years - 85 Years
Healthy Volunteers
Not accepted

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.
  • 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.

Study Details

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.

Key Dates

First listed
Jan 14, 2025
Start date
Jan 1, 2026
Status verified
Sep 2025
Primary completion
Mar 31, 2027
Completion
May 31, 2027

Study Design

Enrollment
30 participants (estimated)
Allocation
NON_RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
TREATMENT

Arms

  • Experimental: Low dose
    25 mg BID
  • Experimental: High dose
    50 mg BID

Primary Outcome Measure

Incidence and severity of Treatment Emergent Adverse Events (TEAEs) [ Time Frame: 13 months ]

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