Actively Recruiting
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)
Led by Aplagon Oy · Updated on 2025-01-30
10
Participants Needed
1
Research Sites
69 weeks
Total Duration
On this page
Sponsors
A
Aplagon Oy
Lead Sponsor
T
TRACER Europe BV
Collaborating Sponsor
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
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)
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Males and females aged 40-85 years
- Patients with PAOD/CLI Rutherford categories 1-4 and category 5 with Wlfl wound grade 0 or 1
- Estimated glomerular filtration rate (eGFR) >46 mL/min/1.73 m2
- CT angiography with contrast performed within 3 months before first PET scan with results available
- No surgical or endovascular intervention for PAOD within 1 year before first PET/CT scan or planned between inclusion and last PET scan
- Ability to communicate well and provide informed consent
- Premenopausal women willing to use highly effective contraception for 195 days after dosing
- Men willing to use highly effective contraception for 105 days after dosing, including condom use during first 15 days
- Ability to understand all study-related information in Dutch
- Healthy volunteers aged 40-80 years
- Healthy status confirmed by medical history, physical exam, vital signs, ECG, lab tests, and urinalysis
- No diagnosis of diabetes, pre-diabetes or insulin resistance
- Normal eGFR
- Premenopausal women willing to use highly effective contraception for 195 days after dosing
- Men willing to use highly effective contraception for 105 days after dosing, including condom use during first 15 days
- Ability to understand all study-related information in Dutch
You will not qualify if you...
- Acute limb-threatening ischemia or embolic disease
- Existing aneurysm requiring surgical intervention
- History of or conditions causing impaired hemostasis or increased bleeding risk
- Cerebrovascular event within past year
- Diagnosis of autoimmune diabetes or HbA1c >10% at screening
- Current use of anticoagulant therapy
- Treatment with combined antiplatelet agents (except single agent aspirin up to 100 mg or clopidogrel up to 75 mg daily)
- Use of NSAIDs or SSRIs within 2 weeks prior to dosing
- Major surgery, trauma, endovascular intervention within 90 days or organ biopsy or diagnostic angiography within 30 days prior to screening
- Uncontrolled hypertension (systolic >160 mmHg or diastolic >100 mmHg)
- Low hemoglobin or abnormal platelet or leukocyte counts
- Prolonged plasma prothrombin time or activated partial thromboplastin time
- History of heparin-induced thrombocytopenia
- Significant liver disease or severe chronic kidney disease
- Active or recent malignancy within 1 year except cured localized skin cancer
- History of metastatic malignancy
- Pregnant or lactating women
- Allergy to heparin or antiplatelet agents
- Participation in investigational drug/device study within 30 days prior to screening
- Prior treatment with antibody or gene therapy products
- Known antiphospholipid antibody syndrome or thrombophilia
- History of severe infection, vasculitis, autoimmune disease, IBD, or Crohn's disease
- Any condition interfering with study conduct or posing unacceptable risk
- Inability or unwillingness to comply with protocol
- History of drug or alcohol abuse in past 12 months (patients) or 3 months (healthy volunteers)
- Healthy volunteers with any cardiovascular disease signs, abnormal ankle-brachial index, hypertension (systolic >140 or diastolic >90), or medical history of aneurysm
- Use of any anticoagulant or antiplatelet agents (except recommended aspirin) within past 12 months (healthy volunteers)
- Regular medication use except vitamins (healthy volunteers)
- Medical history of atrial fibrillation, mechanical heart valve (healthy volunteers)
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
The University Medical Center Groningen
Groningen, Netherlands
Actively Recruiting
Research Team
V
Verhaar, MD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
OTHER
Number of Arms
1
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