Overview
Sponsor-declared trial summary
Phase
Human pharmacology (Phase I) - First administration to humans
Status
Ongoing, recruiting
Participants planned
78
Countries
1
Sites
1
Healthy Volunteers
Key facts
- Sponsor
- AC Immune S.A.
- 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
- 21 Jan 2026 → ongoing
- Decision date (initial)
- 2026-01-13
- 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
Healthy Volunteers
Sponsors and contacts
Sponsor organisations, regulatory contacts, third parties
AC Immune S.A.
- Sponsor organisation
- AC Immune S.A.
- Address
- Batiment B Epfl Innovation Park
- City
- Lausanne
- Postcode
- 1015
- Country
- Switzerland
Scientific contact point
- Organisation
- AC Immune S.A.
- Contact name
- Clinical Trial Information
Public contact point
- Organisation
- AC Immune S.A.
- Contact name
- Clinical Trial Information
Locations
1 EU/EEA country · 1 investigational sites
By country
| Country | MS status | Planned subjects | Sites |
|---|---|---|---|
| Netherlands | Ongoing, recruiting | 78 | 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 | 2026-01-21 | 2026-01-28 |
Application history
1 submissions — initial application plus substantial / non-substantial modifications
| # | Type | Code | Submitted | Reference MS | Conclusion | Decision date |
|---|---|---|---|---|---|---|
| 1 | INITIAL | IN | 2025-11-17 | Netherlands | Acceptable 2026-01-13
|
2026-01-13 |