Study identifier:D9690C00004
ClinicalTrials.gov identifier:NCT06053424
EudraCT identifier:N/A
CTIS identifier:2023-505471-78-00
A Phase 1b Open Label Positron Emission Tomography Study to Assess Changes in Abdominal [11C]AZ14132516 Uptake Following Administration of Single Doses of AZD7798 to Healthy Participants and Patients with Crohn’s Disease
Crohn’s disease
Phase 1
Yes
AZD7798, [11C]AZ14132516
All
12
Interventional
20 Years - 65 Years
Allocation: Non-randomized
Endpoint Classification: -
Intervention Model: Sequential Assignment
Masking: -
Primary Purpose: Treatment
Verified 01 Nov 2024 by AstraZeneca
AstraZeneca
-
The purpose of this study is to measure the changes in small bowel uptake of radioligand [11C]AZ14132516 after IV administration of a single dose of AZD7798 in healthy participants and participants with Crohn’s disease. Study details include: - The study duration will be variable (adaptive design). - There will be 5 in-person study visits: 1 screening visit, 1 visit for the baseline PET examination, 1 residential (24h) visit for AZD7798 administration and 2 visits for repeated PET examinations. There will be a final follow-up virtual visit (telephone call).
No locations available
Arms | Assigned Interventions |
---|---|
Experimental: AZD7798 Arm consists of up to 6 sequential panels: Healthy participant panel 1, Healthy participant panel 2, Healthy participant panel 3, Crohn's disease panel 1, Crohn's disease panel 2, Optional panel | Drug: AZD7798 Solution Drug: [11C]AZ14132516 Radioligand |