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Clinical trial

Phase 1 Study Evaluating the Safety of [11C]MeDAS Myelin-Targeting PET Agent in Humans

ID
Name
MeDAS-001
Description
This study evaluates the safety of \[11C\]MeDAS, a PET radiotracer.
Trial arms
Trial start
2025-03-01
Estimated PCD
2025-12-01
Trial end
2025-12-01
Status
Not yet recruiting
Phase
Early phase I
Treatment
[11C]MeDAS
PET radiotracer
Arms:
Single Arm: Healthy subjects
Other names:
Myeliviz
Size
20
Primary endpoint
Radiation dosimetry
Less than or equal to 2 hours
Biodistribution analysis
Less than or equal to 2 hours
Metabolism analysis
Less than or equal to 2 hours
Pharmacokinetic analysis based on PET scan data
Less than or equal to 2 hours
Analysis of time-dependent radiotracer distribution based on arterial blood sampling
Less than or equal to 2 hours
Eligibility criteria
Inclusion Criteria: * Subject reports no known physical diseases of the central nervous system including no history of mental health disorders. * Capable of giving informed consent * Efforts will be made to include approximately equal numbers of women and men. Efforts will be made to include individuals of diverse ethnicities, as reflected in the local clinic population. Exclusion Criteria: * Age \<18 or \>65 * History of malignant hypertension or hypertensive crisis * Known infectious disease requiring treatment during the course of the study * Subject reported history of substance abuse * inability to undergo an MRI or PET scan
Protocol
{'studyType': 'INTERVENTIONAL', 'phases': ['EARLY_PHASE1'], 'designInfo': {'allocation': 'NA', 'interventionModel': 'SINGLE_GROUP', 'primaryPurpose': 'DIAGNOSTIC', 'maskingInfo': {'masking': 'NONE'}}, 'enrollmentInfo': {'count': 20, 'type': 'ESTIMATED'}}
Updated at
2024-03-18

1 organization

1 product

1 indication

Organization
Robert Fox
Product
[11C]MeDAS
Indication
Healthy