Overview
Sponsor-declared trial summary
Phase
Human pharmacology (Phase I) - First administration to humans
Status
Ongoing, recruiting
Participants planned
124
Countries
1
Sites
1
Autoimmune diseases
Key facts
- Sponsor
- Zealand Pharma A/S
- Participant type
- Healthy volunteers
- Age range
- 18-64 years
- Gender
- Male and Female
- Therapeutic area
- Diseases [C] - Immune System Diseases [C20]
- Trial duration
- 10 Feb 2026 → ongoing
- Decision date (initial)
- 2024-10-28
- Transition trial
- No
- Low-intervention
- No
- Rare-disease indication
- No
- Vulnerable population
- No
External identifiers
- EU CT number
- 2023-509929-51-00
- WHO UTN
- U1111-1305-8892
Trial design
CTIS Part I — objectives, methods, condition coding
Conditions and MedDRA coding
Autoimmune diseases
Sponsors and contacts
Sponsor organisations, regulatory contacts, third parties
Zealand Pharma A/S
- Sponsor organisation
- Zealand Pharma A/S
- Address
- Sydmarken 11
- City
- Soeborg
- Postcode
- 2860
- Country
- Denmark
Scientific contact point
- Organisation
- Zealand Pharma A/S
- Contact name
- Clinical Trial Information Desk
Public contact point
- Organisation
- Zealand Pharma A/S
- Contact name
- Clinical Trial Information Desk
Locations
1 EU/EEA country · 1 investigational sites
By country
| Country | MS status | Planned subjects | Sites |
|---|---|---|---|
| Netherlands | Ongoing, recruiting | 124 | 1 |
| Rest of world | — | 0 | — |
Investigational sites
Centre for Human Drug Research
Immunology, Zernikedreef 8, 2333 CL, Leiden
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 | 2024-11-05 | 2024-11-12 |
Oversight and notifications
Regulatory notifications under CTR Articles 38, 52, 53, 54 and 77
Temporary halts 1 · Art. 38 CTR
Temporary halt TH-116392
- Halt date
- 2026-01-16
- Member states concerned
- Netherlands
- Publication date
- 2026-01-26
- Reason
- Sponsor decision
- Benefit-risk balance changed
- No
- Treatment stopped
- No
Application history
6 submissions — initial application plus substantial / non-substantial modifications
| # | Type | Code | Submitted | Reference MS | Conclusion | Decision date |
|---|---|---|---|---|---|---|
| 1 | INITIAL | IN | 2024-08-19 | Netherlands | Acceptable 2024-10-28
|
2024-10-28 |
| 2 | SUBSTANTIAL MODIFICATION | SM-1 | 2025-03-25 | Netherlands | Acceptable 2025-04-02
|
2025-04-02 |
| 3 | NON SUBSTANTIAL MODIFICATION | NSM-1 | 2025-06-17 | Netherlands | Acceptable 2025-04-02
|
2025-06-17 |
| 4 | SUBSTANTIAL MODIFICATION | SM-2 | 2025-09-01 | Netherlands | Acceptable 2025-10-10
|
2025-10-10 |
| 5 | NON SUBSTANTIAL MODIFICATION | NSM-2 | 2025-11-04 | Netherlands | Acceptable 2025-10-10
|
2025-11-04 |
| 6 | SUBSTANTIAL MODIFICATION | SM-3 | 2026-02-03 | Netherlands | Acceptable 2026-02-18
|
2026-02-18 |