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)

Recruiting Early Phase 1 Interventional Study
Peripheral Arterial Occlusive Disease Critical Limb Ischemia
No Placebo Group Every participant receives an active treatment — no one gets a placebo. Healthy Volunteers Welcome You do not need to have the condition being studied to take part.
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At a Glance
Age
40 – 85
Sex
Any
Trial phase
Early Phase 1
Study type
Interventional
Purpose
Other
Participants needed
10 (estimated)
Sponsor
Aplagon Oy · Industry
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About This Trial
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 \[89Zr\]…
Trial Locations
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Eligibility Criteria
INCLUSION CRITERIA PATIENTS 1. Males and females aged 40-85 years. 2. PAOD/CLI patients Rutherford categories 1-4 and category 5 with Wlfl wound grade of 0 or 1. 3. Estimated glomerular filtration rate (eGFR) \>46 mL/min/1.73 m2 as per calculation of Chronic Kidney Disease Epidemiology Collaboratio…
Contacts

Verhaar, MD

0031622989025

anne-fleur@tracercro.com

CONTACT