A Microdose Trial Investigating Binding of [68Ga]Ga-DOTA-CYS-ATH001 in Healthy Subjects and Different Patient Groups.
NCT Number: NCT06562361
Status: RECRUITING
Study Type: INTERVENTIONAL
Phases: EARLY_PHASE1
Conditions: MASH|PSC|Fibrostenotic Crohn's Disease|Healthy Volunteers
Interventions: DRUG: [68Ga]Ga-DOTA-Cys-ATH001
Sponsor: Antaros Medical
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 30
Study Design: Allocation: NA|Intervention Model: SINGLE_GROUP|Masking: NONE|Primary Purpose: DIAGNOSTIC
Start Date: 2024-08
Completion Date: 2026-03
Locations: CTC Karolinska, Stockholm, SE-171 64 S, Sweden|CTC Akademiska Uppsala University Hospital, Entrance 85, 2nd level, Uppsala, SE-751 85, Sweden|Section of Gastroenterology/Hepatology, Uppsala University Hospital, Uppsala, SE-751 85, Sweden

Summary:
The goal of this clinical trial is to use positron emission tomography (PET) to evaluate and compare the binding of the novel tracer \[68Ga\]Ga-DOTA-Cys-ATH001 in the liver and/or gastrointestinal tract between healthy volunteers and different patient groups including patients with metabolically caused steatohepatitis (MASH), patients with fibrostenotic Crohn´s Disease (CD) and patients with primary sclerosing cholangitis (PSC).The study will also assess the safety of a microdose of 68Ga\]Ga-DOTA-Cys-ATH001 and how it is distributed in different parts of the body. The main questions the study aims to answer are:

* What does the uptake of the \[68Ga\]Ga-DOTA-Cys-ATH001 PET-tracer look like in the liver of healthy subjects, and in that of patients with MASH and PSC?
* What does the uptake of the \[68Ga\]Ga-DOTA-Cys-ATH001 PET-tracer look like in the GI tract of healthy subjects, and that of patients with fibrostenotic CD?
* How much \[68Ga\]Ga-DOTA-Cys-ATH001 PET-tracer can be found in the blood after injection?
* How is \[68Ga\]Ga-DOTA-Cys-ATH001 uptake distributed in the body?
* What medical problems do participants have when receiving \[68Ga\]Ga-DOTA-Cys-ATH001?

Participants will:

Receive one administration of \[68Ga\]Ga-DOTA-Cys-ATH001, after which examination with PET is performed. Magnetic Resonance Imaging (MRI) is also used in the study to create a detailed picture of the body and its function which will facilitate the interpretation of the results of the PET examination. A subset of participants will have blood samples collected after the tracer administration to assess the blood levels of the tracer over time.

A subset of participants will come back for a second visit where they will receive a second administration of \[68Ga\]Ga-DOTA-Cys-ATH001, followed by PET and MRI.

A health check-up is performed before dosing, and a safety assessment will be performed after dosing. A remote follow-up visit is performed the day after the dosing visit.

Primary Outcome Measures: [68Ga]Ga-DOTA-Cys-ATH001 uptake in the whole liver of healthy subjects compared with patients with MASH and PSC, Difference in \[68Ga\]Ga-DOTA-Cys-ATH001 mean standardized uptake value (SUV) in the whole liver of healthy subjects (cohort 1), compared with patients with MASH (cohort 2 and 3) and PSC patients (cohort 5)., Assessed during the intervention|[68Ga]Ga-DOTA-Cys-ATH001 uptake in the GI tract of healthy subjects compared with patients with fibrostenotic CD, Difference in \[68Ga\]Ga-DOTA-Cys-ATH001 SUV in the GI tract of healthy subjects (cohort 1) compared with patients with fibrostenotic CD (cohort 4)., Assessed during the intervention
Secondary Outcome Measures: [68Ga]Ga-DOTA-Cys-ATH001 PET-tracer PK in arterial and venous plasma, \[68Ga\]Ga-DOTA-Cys-ATH001 PET-tracer PK (radioactivity associated with the parent compound) in arterial and venous plasma for up to 125 minutes after injection., Assessed 5 minutes to 125 minutes post-dose
Other Outcome Measures: Whole-body dosimetry of [68Ga]Ga-DOTA-Cys-ATH001 PET tracer in healthy subjects and patients with presumed MASH., Whole-body dosimetry of \[68Ga\]Ga-DOTA-Cys-ATH001 PET tracer in healthy subjects (cohort 1a) and patients with presumed MASH (cohort 2a)., Assessed during the intervention|Safety of [68Ga]Ga-DOTA-Cys-ATH001 PET tracer, Safety of \[68Ga\]Ga-DOTA-Cys-ATH001 PET tracer as assessed by

* Frequency of, seriousness, and intensity of AEs.
* Frequency of clinically significant changes in vital signs, ECG, safety laboratory measurements (hematology, clinical chemistry, coagulation, and urinalysis) and physical examination findings.
* Frequency of injection site reactions., Assessed up to 48 hours post intervention