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A Phase I/II Seamless Adaptive, Open label study to assess Safety, Tolerability, Radiation Dosimetry, Biodistribution, and diagnostic ability of a Novel 18F-labelled Tracer, SYN2, for Positron Emission Tomography in Myocardial Perfusion Imaging (SAFER) in Healthy Volunteers (phase I) and patients with suspected Coronary Artery Disease (phase II)

Trial Profile

A Phase I/II Seamless Adaptive, Open label study to assess Safety, Tolerability, Radiation Dosimetry, Biodistribution, and diagnostic ability of a Novel 18F-labelled Tracer, SYN2, for Positron Emission Tomography in Myocardial Perfusion Imaging (SAFER) in Healthy Volunteers (phase I) and patients with suspected Coronary Artery Disease (phase II)

Status: Completed
Phase of Trial: Phase I/II

Latest Information Update: 21 Apr 2025

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At a glance

  • Drugs 18F synapsin 2 (Primary)
  • Indications Coronary artery disease
  • Focus Adverse reactions; First in man
  • Acronyms SAFER
  • Sponsors Synektik S.A

Most Recent Events

  • 01 Apr 2025 Results of phase I study, published in the Journal of Nuclear Medicine.
  • 26 May 2023 Status changed from recruiting to completed.
  • 08 Feb 2022 New trial record

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