Overview
Sponsor-declared trial summary
Phase
Human pharmacology (Phase I) - First administration to humans
Status
Ongoing, recruiting
Participants planned
123
Countries
1
Sites
1
Alzheimer’s Disease
Key facts
- Sponsor
- Muna Therapeutics ApS
- Participant type
- Healthy volunteers
- Age range
- 18-64 years, 65+ years
- Gender
- Male and Female
- Therapeutic area
- Diseases [C] - Nervous System Diseases [C10]
- Trial duration
- 5 Sep 2025 → ongoing
- Decision date (initial)
- 2025-09-04
- Transition trial
- No
- Low-intervention
- No
- Rare-disease indication
- No
- Vulnerable population
- Yes
Trial design
CTIS Part I — objectives, methods, condition coding
Conditions and MedDRA coding
Alzheimer’s Disease
| Version | Level | Code | Term | System organ class |
|---|---|---|---|---|
| 20.0 | LLT | 10001896 | Alzheimer's disease | 10029205 |
Sponsors and contacts
Sponsor organisations, regulatory contacts, third parties
Muna Therapeutics ApS
- Sponsor organisation
- Muna Therapeutics ApS
- Address
- Nordre Fasanvej 215
- City
- Frederiksberg
- Postcode
- 2000
- Country
- Denmark
Scientific contact point
- Organisation
- Muna Therapeutics ApS
- Contact name
- Moneypenny Answering Service on behalf of Muna Therapeutics ApS
Public contact point
- Organisation
- Muna Therapeutics ApS
- Contact name
- Moneypenny Answering Service on behalf of Muna Therapeutics ApS
Locations
1 EU/EEA country · 1 investigational sites
By country
| Country | MS status | Planned subjects | Sites |
|---|---|---|---|
| Netherlands | Ongoing, recruiting | 123 | 1 |
| Rest of world | — | 0 | — |
Investigational sites
Pharmaceutical Research Associates Group B.V.
Program Management, Van Swietenlaan 6, 9728 NZ, Groningen
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 |
|---|---|---|---|---|---|
| Netherlands | 2025-09-05 | 2025-09-08 |
Application history
3 submissions — initial application plus substantial / non-substantial modifications
| # | Type | Code | Submitted | Reference MS | Conclusion | Decision date |
|---|---|---|---|---|---|---|
| 1 | INITIAL | IN | 2025-07-14 | Netherlands | Acceptable 2025-09-04
|
2025-09-04 |
| 2 | NON SUBSTANTIAL MODIFICATION | NSM-1 | 2025-10-21 | Netherlands | Acceptable 2025-09-04
|
2025-10-21 |
| 3 | SUBSTANTIAL MODIFICATION | SM-1 | 2026-02-04 | Netherlands | Acceptable 2026-02-26
|
2026-02-26 |