Early Phase 0 Trial Using 68GaGa-DOTA-Cys-ATH001 PET Tracer to Study Liver and GI Tract in Healthy Adults and Patients with MASH, PSC, and Crohns Disease

What this Trial Is About

Researchers are evaluating the binding of a new PET tracer called 68GaGa-DOTA-Cys-ATH001 in the liver and gastrointestinal tract. The study compares healthy volunteers with patients who have metabolically caused steatohepatitis MASH, fibrostenotic Crohns Disease CD, and primary sclerosing cholangitis PSC. This first-in-human, phase 0, multi-center trial aims to understand tracer uptake patterns and assess its safety and distribution in the body. Participants receive a single intravenous injection of up to 100 micrograms of the tracer, followed by PET and MRI scans to visualize tracer binding and body function. Some participants in specific cohorts undergo a second injection and imaging visit within six weeks to test tracer reliability. Blood samples are collected from certain groups to measure tracer levels over time. Safety assessments and remote follow-up calls are also part of the study protocol. During the study, participants will have health checks and eligibility screening before dosing. Imaging includes whole-body PETMRI scans and specific examinations like FibroScan for some groups. Safety is monitored through vital signs, ECG, lab tests, and injection site observations. Follow-up calls check on any side effects or medication use. The trial involves 2 to 3 visits depending on the participants cohort and includes detailed assessments of tracer uptake and pharmacokinetics.

A Microdose Trial Investigating Binding of [68Ga]Ga-DOTA-CYS-ATH001 in Healthy Subjects and Different Patient Groups.