Healthy Volunteers Clinical Trial
Official title:
A Phase 0 Open Label Positron Emission Tomography Study to Assess the Biodistribution and Binding Characteristics of [11C]AZ14132516 Following Administration to Healthy Participants
The purpose of this study is to measure the regional distribution and binding of [11C]AZ14132516 to CCR9 in the abdomen using PET-CT examination in healthy participants. Study details include: The study duration will be up to 60 days. The IV radioligand [11C]AZ14132516 will be administered at PET-CT examination: Visit 2 for the pilot panel; Visit 2 and 3 in the main panel. There will be 2 study visits for the pilot panel and 3 study visits for the main panel.
This is a Phase 0, first in human (FIH) open label radioligand development study in healthy male and female participants. This radioligand development study will consist of two sequential panels: Pilot panel (n = up to 3) Main panel (n = up to 6) The purpose of the pilot panel is to perform initial PET-CT examinations using radioligand [11C]AZ14132516 and to optimise the imaging protocol. Up to 3 participants are planned to be included in this panel. Participants will attend the PET unit for a single visit and will be administered a single intravenous microdose of [11C]AZ14132516 (≤ 10μg regardless of body weight, approximately 400 MBq/70kg radioactivity) followed by a single PET-CT examination. The purpose of the main panel is to assess [11C]AZ14132516 kinetics, binding characteristics, develop the quantitative analysis protocol and assess reproducibility of the analysis. Six participants are planned to be included in this panel. Participants will attend the PET unit for a baseline visit with administration of a single intravenous microdose of [11C]AZ14132516 followed by a PET-CT examination. Participants will return for a repeat visit 10 to14 days later where a second intravenous microdose of [11C]AZ14132516 will be administered followed by a second PET-CT examination. ;
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