Actively Recruiting
Safety, Tolerability, and Biodistribution of [89Zr]Zr-DFO-APAC (Phase 0) in Adults With Peripheral Arterial Occlusive Disease / Critical Limb Ischemia and Healthy Volunteers - an Open Label PET Study
Led by Aplagon Oy · Updated on 2025-01-30
10
Participants Needed
1
Research Sites
N/A
Total Duration
On this page
Sponsors
A
Aplagon Oy
Lead Sponsor
T
TRACER Europe BV
Collaborating Sponsor
AI-Summary
What this Trial Is About
Researchers are evaluating the safety, tolerability, and biodistribution of a drug called [89Zr]Zr-DFO-APAC in people aged 40 to 85 years with peripheral arterial occlusive disease (PAOD) or critical limb ischemia (CLI), as well as in healthy volunteers. This early phase 0 clinical trial aims to understand how the drug behaves in the body, including its binding to arteries and lesions, and its internal radiation dosimetry. The sponsor of this study is Aplagon Oy. All participants will receive a single intravenous injection of [89Zr]Zr-DFO-APAC at a dose of 15 MBq. After the injection, whole-body PET/CT scans will be performed on days 1, 3, and 7 to track the drug's distribution and retention. A follow-up visit will take place 7 to 14 days after dosing to monitor safety and tolerability. During the study, participants will undergo several PET/CT scans to monitor the drug's location and effects. Researchers will assess safety by tracking any treatment-emergent adverse events for up to 21 days. Participants will also have screenings including medical history and lab tests to confirm eligibility. The total participation time includes the initial dosing, imaging visits, and a follow-up safety assessment period.
CONDITIONS
Brief 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 to 85 years
- PAOD/CLI patients with Rutherford categories 1-4 or category 5 with WIfI wound grade 0 or 1
- Estimated glomerular filtration rate (eGFR) greater than 46 mL/min/1.73 m2
- CT angiography with contrast performed within 3 months before first PET scan
- No surgical or endovascular intervention for PAOD within 1 year before first PET scan or planned during study
- Ability to provide informed consent and communicate well with investigator
- Premenopausal women and men willing to use highly effective contraception for specified durations after dosing
- Ability to understand study-related information in Dutch
- Healthy volunteers aged 40 to 80 years with no active or chronic disease
- No diagnosis of diabetes, pre-diabetes, or insulin resistance
- Normal eGFR as per CKD-EPI calculation
You will not qualify if you...
- Acute limb-threatening ischemia or embolic disease
- Aneurysm requiring surgical intervention
- History or conditions with impaired hemostasis or increased bleeding risk
- Cerebrovascular events within past year
- Autoimmune diabetes diagnosis or HbA1c over 10% at screening
- Current use of anticoagulants or combined antiplatelet agents (except single agent aspirin or clopidogrel)
- Use of NSAIDs or SSRIs within 2 weeks before dosing
- Recent major surgery, trauma, endovascular intervention, organ biopsy, or diagnostic angiography
- Uncontrolled hypertension (systolic >160 mmHg or diastolic >100 mmHg)
- Abnormal blood counts or coagulation times
- History of heparin-induced thrombocytopenia
- Significant liver disease or severe chronic kidney disease
- Active malignancy or recent cancer treatment except cured skin cancers
- Pregnant or lactating women
- Known allergies to heparin or antiplatelet agents
- Participation in other investigational studies within 30 days
- History of antibody or gene therapy treatments
- Known thrombophilia or autoimmune diseases affecting blood vessels
- Conditions that interfere with study conduct or pose unacceptable risk
- History of drug or alcohol abuse within past 12 months (patients) or 3 months (healthy volunteers)
- For healthy volunteers: signs of cardiovascular disease, abnormal ankle-brachial index, hypertension above specified limits, or use of regular medications except vitamins
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - 7 days
Participants receive a single intravenous injection of [89Zr]Zr-DFO-APAC followed by whole-body PET/CT scans.
1 injection visit and PET/CT scans on days 1, 3, and 7
Duration - Up to 21 days from treatment
Participants are monitored for safety and tolerability after treatment.
Visits as needed for safety monitoring
Trial Site Locations
Total: 1 location
1
The University Medical Center Groningen
Groningen, Netherlands
Actively Recruiting
Research Team
V
Verhaar, MD
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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