RecruitingEarly Phase 1

Safety, Tolerability, and Biodistribution of [89Zr]Zr-DFO-APAC in Subjects With PAOD/CLI and Healthy Volunteers (Acronyms: 89Zr = Zirconium-89, DFO = Desferrioxamine, APAC = AntiPlatelet AntiCoagulant, PET/CT = Positron Emission Tomography/Computed Tomography)

Netherlands10 participantsStarted 2024-02-01

Plain-language summary

The goal of this Phase 0 clinical trial is to evaluate safety and biodistribution of \[89Zr\]Zr-DFO-APAC in patients with peripheral arterial occlusive disease / critical limb ischemia (PAOD/CLI) and healthy volunteers. The main questions it aims to answer are: * What is the safety, tolerability and pharmacokinetic profile (PK: both systemic and local vascular injury site-specific PK) of \[89Zr\]Zr-DFO-APAC? * What is the biodistribution and internal radiation dosimetry of the tracer dose of \[89Zr\]Zr-DFO-APAC? * What is the binding and retention time of \[89Zr\]Zr-DFO-APAC to arteries and atherosclerotic or microvascular lesions? Participants will receive a dose of the \[89Zr\]Zr-DFO-APAC (IMP) and PET/CT imaging is performed on days 1, 3 and 7, and follow-up visit 7-14 days post IMP dosing.

Who can participate

Age range40 Years – 85 Years

SexALL

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Inclusion criteria

✓. Males and females aged 40-85 years.
✓. PAOD/CLI patients Rutherford categories 1-4 and category 5 with Wlfl wound grade of 0 or 1.
✓. Estimated glomerular filtration rate (eGFR) \>46 mL/min/1.73 m2 as per calculation of Chronic Kidney Disease Epidemiology Collaboration (CKD-EPI).
✓. CT angiography with contrast agent performed of within 3 months of the patients' first PET-scan as part of diagnostics of PAOD, with results available in the subject's medical records.
✓. No surgical or endovascular intervention for PAOD within 1 year of the first PET/CT-scan or planned between inclusion and the patients' last PET-scan.
✓. Provision of valid informed consent and capability to communicate well with the investigator.
✓. Pre-menopausal woman must be willing to practise highly effective contraception for 195 days after IMP administration.
✓. Men must be willing to practise highly effective contraception for 105 days after IMP administration, including condom use during the first 15 days to prevent transmission of 89-Zr to a partner of childbearing potential.

Exclusion criteria

What they're measuring

Incidence of treatment emergent adverse events (AE) (safety and tolerability)

Timeframe: Study duration (Up to 21 days)

Trial details

NCT IDNCT06204237

SponsorAplagon Oy

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2025-06

Contact for this trial

Verhaar, MD

0031622989025 anne-fleur@tracercro.com

View on ClinicalTrials.gov More Peripheral Arterial Occlusive Disease trials