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

NCT06562361 · Status: RECRUITING · Phase: EARLY_PHASE1 · Type: INTERVENTIONAL · Enrollment: 30

Last updated 2024-08-29

No results posted yet for this study

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.

Conditions

  • MASH
  • PSC
  • Fibrostenotic Crohn's Disease
  • Healthy Volunteers

Interventions

DRUG

[68Ga]Ga-DOTA-Cys-ATH001

Target dose of 200MBq \[68Ga\]Ga-DOTA-Cys-ATH001 corresponding to a maximum mass dose of 100 µg, administered as an intravenous bolus dose.

Sponsors & Collaborators

  • Antaros Medical

    lead INDUSTRY

Principal Investigators

  • Johan Vessby · Section of Gastroenterology/Hepatology SE-751 85 Uppsala, Sweden

Study Design

Allocation
NA
Purpose
DIAGNOSTIC
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2024-08-31
Primary Completion
2025-12-31
Completion
2026-03-31

Countries

  • Sweden

Study Locations

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06562361 on ClinicalTrials.gov