Clinical trial • Phase I • Neurology|Other

[11C]MODAG-005 (radiolabelled PET radioligand) for Parkinson's disease | Multiple system atrophy

Phase I trial of [11C]MODAG-005 (radiolabelled PET radioligand) for Parkinson's disease | Multiple system atrophy.

Overview

Trial Therapeutic Area
Neurology|Other
Trial Disease
Parkinson's disease | Multiple system atrophy
Trial Stage
Phase I
Drug Modality
Radiopharmaceutical

Key dates

Initial CTIS Submission Date
13-02-2026
First CTIS Authorization Date
04-05-2026

Trial design

open-label, age-matched healthy controls (amhc) as comparator; no drug comparator specified. Phase I trial across 1 site in Germany.

Open Label
Yes
Comparator
Age-matched healthy controls (AMHC) as comparator; no drug comparator specified.
Target Sample Size
28

Eligibility

Recruits 28 No vulnerable population selected (isVulnerablePopulationSelected: false)..

Vulnerable Population
No vulnerable population selected (isVulnerablePopulationSelected: false).

Recruitment

Planned Sample Size
28
Recruitment Window Months
15

Geography

Total Number Of Sites
1
Total Number Of Participants
28

Germany

Earliest CTIS Part Ii Submission Date
22-04-2026
Latest Decision Or Authorization Date
04-05-2026
Processing Time Days
12
Number Of Sites
1
Number Of Participants
28

Sites

Site Name
Universitätsklinikum Tübingen
Department Name
Department Radiologie
Contact Person Name
Christian la Fougère
Number Of Participants
28

Sponsor

Primary sponsor

Full Name
Modag GmbH
Organisation Type
Pharmaceutical company
Country Of Registered Address
Germany

Investigational products

Investigational Product Name
[11C]MODAG-005
Active Substance
[11C]MODAG-005 (radiolabelled PET radioligand)
Modality
Radiopharmaceutical
Authorisation Status
Investigational (PET radioligand)

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