Overview
Sponsor-declared trial summary
Phase
Human pharmacology (Phase I) - Other
Status
Ongoing, recruiting
Participants planned
8
Countries
1
Sites
1
Healthy Volunteers
Key facts
- Sponsor
- AbbVie Deutschland GmbH & Co. KG
- Participant type
- Healthy volunteers
- Age range
- 18-64 years
- Gender
- Male
- Therapeutic area
- Phenomena and Processes [G] - Metabolism [G03]
- Trial duration
- 16 Apr 2026 → ongoing
- Decision date (initial)
- 2025-04-25
- 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
Healthy Volunteers
| Version | Level | Code | Term | System organ class |
|---|---|---|---|---|
| 20.0 | SOC | 10037175 | Psychiatric disorders | 7 |
Sponsors and contacts
Sponsor organisations, regulatory contacts, third parties
AbbVie Deutschland GmbH & Co. KG
- Sponsor organisation
- AbbVie Deutschland GmbH & Co. KG
- Address
- Knollstrasse
- City
- Ludwigshafen Am Rhein
- Postcode
- 67061
- Country
- Germany
Scientific contact point
- Organisation
- AbbVie Deutschland GmbH & Co. KG
- Contact name
- Global Clinical Trials Helpdesk
Public contact point
- Organisation
- AbbVie Deutschland GmbH & Co. KG
- Contact name
- Global Clinical Trials Helpdesk
Locations
1 EU/EEA country · 1 investigational sites
By country
| Country | MS status | Planned subjects | Sites |
|---|---|---|---|
| Netherlands | Ongoing, recruiting | 8 | 1 |
| Rest of world | — | 0 | — |
Investigational sites
Pharma Bio-Research Group
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 | 2026-04-16 | 2026-05-04 |
Application history
4 submissions — initial application plus substantial / non-substantial modifications
| # | Type | Code | Submitted | Reference MS | Conclusion | Decision date |
|---|---|---|---|---|---|---|
| 1 | INITIAL | IN | 2025-02-21 | Netherlands | Acceptable 2025-04-22
|
2025-04-25 |
| 2 | SUBSTANTIAL MODIFICATION | SM-1 | 2025-07-15 | Netherlands | Acceptable 2025-07-22
|
2025-07-22 |
| 3 | SUBSTANTIAL MODIFICATION | SM-2 | 2026-02-23 | Netherlands | Acceptable 2026-03-20
|
2026-03-20 |
| 4 | NON SUBSTANTIAL MODIFICATION | NSM-1 | 2026-04-09 | Netherlands | Acceptable 2026-03-20
|
2026-04-09 |