NCT06204237

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)

Safety, Tolerability, and Biodistribution of [89Zr]Zr-DFO-APAC (Phase 0) in Subjects With Peripheral Arterial Occlusive Disease / Critical Limb Ischemia (PAOD/CLI) and Healthy Volunteers - an Open Label PET Study (Acronyms: 89Zr = Zirconium-89, DFO = Desferrioxamine, APAC = AntiPlatelet AntiCoagulant, PET/CT = Positron Emission Tomography/Computed Tomography)

• Status: Recruiting
• Phase: EARLY_Phase 1
• Study type: Interventional
• Enrollment: 10 (estimated)
• Sponsor: Aplagon Oy · Industry
• Sex: All
• Age: 40 Years – 85 Years
• Healthy volunteers: Accepted

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.

Conditions

• Peripheral Arterial Occlusive Disease
• Critical Limb Ischemia

Interventions

Type	Name	Description
DRUG	[89Zr]Zr-DFO-APAC	All participants will receive a single i.v. injection of \[89Zr\]Zr-DFO-APAC 15 MBq (Megabecquerel).
RADIATION	PET/CT scan	The IMP administration will be followed by whole-body PET/CT scanning (day 1), and repeated PET/CT scans on days 3 and 7.

Timeline

• Start date: 2024-02-01
• Primary completion: 2025-06-01
• Completion: 2025-06-01
• First posted: 2024-01-12
• Last updated: 2025-01-30

Locations

1 site across 1 country: Netherlands