Overview
Sponsor-declared trial summary
Phase
Human pharmacology (Phase I) - First administration to humans
Status
Ongoing, recruiting
Participants planned
72
Countries
1
Sites
1
ALS and related disorders like frontotemporal dementia and Alexander disease.
Key facts
- Sponsor
- Molefy Pharma S.L.
- Participant type
- Healthy volunteers
- Age range
- 18-64 years
- Gender
- Male
- Therapeutic area
- Diseases [C] - Nervous System Diseases [C10]
- Trial duration
- 24 Apr 2026 → ongoing
- Decision date (initial)
- 2026-03-10
- Transition trial
- No
- Low-intervention
- No
- Rare-disease indication
- No
- Vulnerable population
- No
Trial design
CTIS Part I — objectives, methods, condition coding
Conditions and MedDRA coding
ALS and related disorders like frontotemporal dementia and Alexander disease.
| Version | Level | Code | Term | System organ class |
|---|---|---|---|---|
| 21.1 | PT | 10068968 | Frontotemporal dementia | 100000004852 |
| 22.1 | PT | 10083059 | Alexander disease | 100000004850 |
| 27.1 | PT | 10002026 | Amyotrophic lateral sclerosis | 100000004852 |
Sponsors and contacts
Sponsor organisations, regulatory contacts, third parties
Molefy Pharma S.L.
- Sponsor organisation
- Molefy Pharma S.L.
- Address
- Camino Las Mantecas Sn
- City
- San Cristobal De La Laguna
- Postcode
- 38320
- Country
- Spain
Scientific contact point
- Organisation
- Molefy Pharma S.L.
- Contact name
- Sergio Capitán Herraiz
Public contact point
- Organisation
- Molefy Pharma S.L.
- Contact name
- Sergio Capitán Herraiz
Locations
1 EU/EEA country · 1 investigational sites
By country
| Country | MS status | Planned subjects | Sites |
|---|---|---|---|
| Spain | Ongoing, recruiting | 72 | 1 |
| Rest of world | — | 0 | — |
Investigational sites
Country notifications
Trial-start, recruitment-start, end and early-termination notifications submitted per Member State
| Country | Trial start | Trial end | Recruitment start | Recruitment end | Early termination |
|---|---|---|---|---|---|
| Spain | 2026-04-24 | 2026-04-27 |
Application history
5 submissions — initial application plus substantial / non-substantial modifications
| # | Type | Code | Submitted | Reference MS | Conclusion | Decision date |
|---|---|---|---|---|---|---|
| 1 | INITIAL | IN | 2025-11-15 | Spain | Acceptable with conditions 2026-03-09
|
2026-03-10 |
| 2 | SUBSTANTIAL MODIFICATION | SM-1 | 2026-03-18 | Spain | Acceptable 2026-03-19
|
2026-03-19 |
| 3 | NON SUBSTANTIAL MODIFICATION | NSM-1 | 2026-04-16 | Spain | Acceptable 2026-03-19
|
2026-04-16 |
| 4 | SUBSTANTIAL MODIFICATION | SM-2 | 2026-04-21 | Spain | Acceptable | 2026-04-24 |
| 5 | NON SUBSTANTIAL MODIFICATION | NSM-2 | 2026-04-24 | Spain | 2026-04-24 |