Phase 0 Study of Safety and Distribution of 89ZrZr-DFO-APAC in Patients with Peripheral Arterial Disease or Critical Limb Ischemia and Healthy Adults Aged 40 to 85

What this Trial Is About

Researchers are evaluating the safety, tolerability, and biodistribution of a drug called 89ZrZr-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 89ZrZr-DFO-APAC at a dose of 15 MBq. After the injection, whole-body PETCT scans will be performed on days 1, 3, and 7 to track the drugs 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 PETCT scans to monitor the drugs 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.

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)