Clinical trial • Phase I • Neurology

AP-2 for Amyotrophic lateral sclerosis | Frontotemporal dementia | Alexander disease

Phase I trial of AP-2 for Amyotrophic lateral sclerosis | Frontotemporal dementia | Alexander disease. 72 participants.

Overview

Trial Therapeutic Area
Neurology
Trial Disease
Amyotrophic lateral sclerosis | Frontotemporal dementia | Alexander disease
Trial Stage
Phase I

Key dates

Initial CTIS Submission Date
15-11-2025
First CTIS Authorization Date
10-03-2026

Trial design

Phase I trial across 1 site in Spain.

Target Sample Size
72

Eligibility

Recruits 72 No vulnerable populations selected; population includes Healthy volunteers; isVulnerablePopulationSelected=false.

Vulnerable Population
No vulnerable populations selected; population includes Healthy volunteers; isVulnerablePopulationSelected=false

Recruitment

Planned Sample Size
72
Recruitment Window Months
5

Geography

Total Number Of Sites
1
Total Number Of Participants
72

Spain

Earliest CTIS Part Ii Submission Date
24-11-2025
Latest Decision Or Authorization Date
24-04-2026
Processing Time Days
151
Number Of Sites
1
Number Of Participants
72

Sites

Site Name
Hospital Universitario De La Princesa
Department Name
Clinical pharmacology
Principal Investigator Name
Dolores Ochoa Mazarro
Principal Investigator Email
mdolores.ochoa@salud.madrid.org
Contact Person Name
Dolores Ochoa Mazarro

Sponsor

Primary sponsor

Full Name
Molefy Pharma S.L.
Organisation Type
Pharmaceutical company
Country Of Registered Address
Spain

Investigational products

Investigational Product Name
AP-2

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