NCT06053424

Positron Emission Tomography (PET) Study of Changes in [11C]AZ14132516 Uptake Following Administration of AZD7798 to Healthy Participants and Patients With Crohn's Disease

A Phase 1b Open Label Positron Emission Tomography Study to Assess Changes in Abdominal [11C]AZ14132516 Uptake Following Administration of Single and Repeat Doses of AZD7798 to Healthy Participants and Patients With Crohn's Disease

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 13 (actual)
• Sponsor: AstraZeneca · Industry
• Sex: All
• Age: 20 Years – 65 Years
• Healthy volunteers: Accepted

Summary

The purpose of this study is to measure the changes in small bowel uptake of radioligand \[11\^C\]AZ14132516 after intravenous (IV) administration of single and repeat doses of AZD7798 in healthy participants and participants with Crohn's disease. Study details include: * The study duration will be variable (adaptive design). * For Panels 1-5, there will be 5 in-person study visits: 1 screening visit, 1 visit for the baseline PET examination, 1 residential (24 hour) visit for AZD7798 administration and 2 visits for repeated PET examinations. There will be a final follow-up virtual visit (telephone call). * For Panel 6, there will be 7 in-person study visits: 1 screening visit, 1 visit for the baseline PET examination, 2 residential (24 hour) visits for AZD7798 administration, 1 visit for pharmacokinetic (PK) blood sample and 2 visits for repeated PET examinations. There will be a final follow-up virtual visit.

Conditions

• Crohn's Disease

Interventions

Type	Name	Description
DRUG	AZD7798	Participants will receive IV infusion of AZD7798 as stated in arm description.
DRUG	[11C]AZ14132516	Participants will receive IV bolus dose of radioligand \[11\^C\]AZ14132516 as stated in arm description.

Timeline

• Start date: 2023-09-25
• Primary completion: 2024-10-08
• Completion: 2024-10-08
• First posted: 2023-09-25
• Last updated: 2025-08-27

Locations

1 site across 1 country: Sweden