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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)

Study acronym: CHASE
StatusUnknown
PhaseEarly Phase 1
SponsorAplagon Oy
Started
View on ClinicalTrials.gov ↗
Record status
This record was last updated January 30, 2025 (before its estimated June 2025 completion). Its status may not reflect the trial's current state.

Record History

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  1. Changed Registry marked status Unknown (sponsor has not verified the record since Sep 2024); last known: Recruiting
  2. Primary and study completion dates: Mar 2025 to Jun 2025
    • Eligibility criteria shortened, about 41 words
    v5
  3. Primary and study completion dates: Jul 2024 to Mar 2025
    • Primary endpoints: 2 to 1
    • Eligibility criteria shortened, about 17 words
    • Study arms: 2 to 1
    v4
  4. Trial status: Not Yet Recruiting to Recruiting
    • Primary and study completion dates: Jun 2024 to Jul 2024
    • Start date changed from estimate of Jan 2024 to Feb 1, 2024
    • Site details revised
    v3
  5. Primary endpoints revised (2)
    • Study title expanded, about 17 words
    • Eligibility criteria shortened, about 3 words
    v2
  6. Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
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.
Trial Details
NCT Number NCT06204237
Lead Sponsor Aplagon Oy
Collaborators: TRACER Europe BV
Conditions
(from sponsor)		 Peripheral Arterial Occlusive Disease, Critical Limb Ischemia
Related terms Chronic Limb-Threatening Ischemia, Peripheral Arterial Occlusive Disease 1
Enrollment 10 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov