Ignite Creation Date:
2024-10-26 @ 3:38 PM
Last Modification Date:
2024-10-26 @ 3:38 PM
Study NCT ID:
NCT06562361
Status:
RECRUITING
Last Update Posted:
None
First Post:
2024-08-14
Brief Title:
A Microdose Trial Investigating Binding of 68GaGa-DOTA-CYS-ATH001 in Healthy Subjects and Different Patient Groups
Sponsor:
None
Organization:
None
Study Overview
Official Title:
A First-In-Human Microdosing Clinical Trial to Investigate Binding of the PET Tracer 68GaGa-DOTA-CYS-ATH001 Targeting PDGFRβ in Healthy Subjects as Compared to Patients With MASH PSC and CD
Status:
RECRUITING
Status Verified Date:
2024-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The goal of this clinical trial is to use positron emission tomography PET to evaluate and compare the binding of the novel tracer 68GaGa-DOTA-Cys-ATH001 in the liver andor gastrointestinal tract between healthy volunteers and different patient groups including patients with metabolically caused steatohepatitis MASH patients with fibrostenotic Crohns Disease CD and patients with primary sclerosing cholangitis PSCThe study will also assess the safety of a microdose of 68GaGa-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 68GaGa-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 68GaGa-DOTA-Cys-ATH001 PET-tracer look like in the GI tract of healthy subjects and that of patients with fibrostenotic CD
How much 68GaGa-DOTA-Cys-ATH001 PET-tracer can be found in the blood after injection
How is 68GaGa-DOTA-Cys-ATH001 uptake distributed in the body
What medical problems do participants have when receiving 68GaGa-DOTA-Cys-ATH001
Participants will
Receive one administration of 68GaGa-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 68GaGa-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
What does the uptake of the 68GaGa-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 68GaGa-DOTA-Cys-ATH001 PET-tracer look like in the GI tract of healthy subjects and that of patients with fibrostenotic CD
How much 68GaGa-DOTA-Cys-ATH001 PET-tracer can be found in the blood after injection
How is 68GaGa-DOTA-Cys-ATH001 uptake distributed in the body
What medical problems do participants have when receiving 68GaGa-DOTA-Cys-ATH001
Participants will
Receive one administration of 68GaGa-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 68GaGa-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
Detailed Description:
This is a first-in-human FIH phase 0 multi-center non-randomized trial to investigate 68GaGa-DOTA-Cys-ATH001 PET-tracer binding in the liver and in the GI tract in healthy subjects and patients with metabolically caused steatohepatitis MASH patients with fibrostenotic Crohns Disease CD and patients with primary sclerosing cholangitis PSC in a total of 5 different cohorts including a sub-trial to assess test-retest reliability and a sub-trial to assess dosimetry The allocation of cohorts is
Cohort 1a n3 Healthy volunteers sub-group dosimetry
Cohort 1b n3 Healthy volunteers sub-group testretest
Cohort 2a n3 Presumed MASH patients sub-group dosimetry
Cohort 2b n3 Presumed MASH patients sub-group testretest
Cohort 3 n6 Verified MASH patients
Cohort 4 n6 Fibrostenotic CD patients
Cohort 5 n6 PSC patients
The participants will come for 2 or 3 visits to the trial site The screening Visit 1 will include an eligibility check and review of health status Participants in cohort 2 and cohort 3 will perform a FibroScan investigation
At Visit 2 participants will come to the trial site for PETMRI and safety assessments The participants will receive a single bolus iv injection of a maximum of 100 µg 68GaGa-DOTA-Cys-ATH001 after which participants will be examined by whole-body PETMRI scans A sub-group of participants in cohort 1 cohort 1a healthy subjects n3 the first 3 participants in this cohort and cohort 2 cohort 2a presumed MASH patients n3 the first 3 participants in this cohort will be participating in a sub-trial to calculate the whole-body dosimetry of the tracer These participants will have one longer PET visit and will be examined by sequential whole-body PETMRI scans to determine tracer biodistribution and clearance At Visit 4 within 6 weeks of Visit 2 participants taking part in the testretest sub-trial Cohorts 1b and 2b will come for a second PETMRI visit which includes a second administration of 68GaGa-DOTA-Cys-ATH001
To determine tracer clearance from blood venous 1a and b and 2a and b and arterial 1b and 2b PK samples will be collected post-dose No PK samples will be taken from cohorts 3 to 5
Safety assessments will take place after the PETMRI vital signs 12-lead ECG safety laboratory sampling and injection site reactions A remote follow-up by telephone Visit 3 will be performed the day after 68GaGa-DOTA-Cys-ATH001 dosing to follow-up on AEs injection site reactions and concomitant medicationFor participants in cohorts 1b and 2b the testretest sub-group a remote follow-up by telephone Visit 5 will be performed the day after 68GaGa-DOTA-Cys-ATH001 dosing to follow-up on AEs injection site reactions and concomitant medication
Cohort 1a n3 Healthy volunteers sub-group dosimetry
Cohort 1b n3 Healthy volunteers sub-group testretest
Cohort 2a n3 Presumed MASH patients sub-group dosimetry
Cohort 2b n3 Presumed MASH patients sub-group testretest
Cohort 3 n6 Verified MASH patients
Cohort 4 n6 Fibrostenotic CD patients
Cohort 5 n6 PSC patients
The participants will come for 2 or 3 visits to the trial site The screening Visit 1 will include an eligibility check and review of health status Participants in cohort 2 and cohort 3 will perform a FibroScan investigation
At Visit 2 participants will come to the trial site for PETMRI and safety assessments The participants will receive a single bolus iv injection of a maximum of 100 µg 68GaGa-DOTA-Cys-ATH001 after which participants will be examined by whole-body PETMRI scans A sub-group of participants in cohort 1 cohort 1a healthy subjects n3 the first 3 participants in this cohort and cohort 2 cohort 2a presumed MASH patients n3 the first 3 participants in this cohort will be participating in a sub-trial to calculate the whole-body dosimetry of the tracer These participants will have one longer PET visit and will be examined by sequential whole-body PETMRI scans to determine tracer biodistribution and clearance At Visit 4 within 6 weeks of Visit 2 participants taking part in the testretest sub-trial Cohorts 1b and 2b will come for a second PETMRI visit which includes a second administration of 68GaGa-DOTA-Cys-ATH001
To determine tracer clearance from blood venous 1a and b and 2a and b and arterial 1b and 2b PK samples will be collected post-dose No PK samples will be taken from cohorts 3 to 5
Safety assessments will take place after the PETMRI vital signs 12-lead ECG safety laboratory sampling and injection site reactions A remote follow-up by telephone Visit 3 will be performed the day after 68GaGa-DOTA-Cys-ATH001 dosing to follow-up on AEs injection site reactions and concomitant medicationFor participants in cohorts 1b and 2b the testretest sub-group a remote follow-up by telephone Visit 5 will be performed the day after 68GaGa-DOTA-Cys-ATH001 dosing to follow-up on AEs injection site reactions and concomitant medication
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None