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)

Early Phase 1

Recruiting

• Conditions: Peripheral Arterial Occlusive Disease; Critical Limb Ischemia
• Interventions: Drug: [89Zr]Zr-DFO-APAC; Radiation: PET/CT scan

• Registration Number: NCT06204237
• Lead Sponsor: Aplagon Oy

Brief 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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2024-01-03
• Study First Submitted QC: 2024-01-03
• Study First Posted: 2024-01-12
• Study Start: 2024-02-01
• Status Verified: 2024-09
• Last Update Submitted: 2025-01-28
• Last Update Posted: 2025-01-30
• Primary Completion: 2025-06
• Study Completion: 2025-06

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 10

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
[89Zr]Zr-DFO-APAC	[89Zr]Zr-DFO-APAC	-
[89Zr]Zr-DFO-APAC	PET/CT scan	-

Primary Outcome Measures

Name	Time	Method
Incidence of treatment emergent adverse events (AE) (safety and tolerability)	Study duration (Up to 21 days)	Occurrence and severity of one or more treatment-emergent AEs from the time of i.v. administration of \[89Zr\]Zr-DFO-APAC until the end of the follow-up period, and changes in plasma/serum clinical chemistry, hematology, coagulation variables, vital signs, ECG, and physical examination findings.

Trial Locations

Locations (1)

The University Medical Center Groningen; 🇳🇱 Groningen, Netherlands