Overview
Sponsor-declared trial summary
Phase
Human pharmacology (Phase I) - Bioequivalence study
Status
Ended
Participants planned
14
Countries
1
Sites
1
Healthy Volunteers
Key facts
- Sponsor
- UCB Biopharma
- Participant type
- Healthy volunteers
- Age range
- 18-64 years
- Gender
- Male and Female
- Therapeutic area
- Phenomena and Processes [G] - Musculoskeletal and Neural Physiological Phenomena [G11]
- Trial duration
- 5 Aug 2024 → 26 Nov 2024
- Decision date (initial)
- 2024-06-12
- Transition trial
- No
- Low-intervention
- No
- Rare-disease indication
- Yes
- Vulnerable population
- No
External identifiers
- EU CT number
- 2023-508388-64-00
- WHO UTN
- U1111-1303-7028
Trial design
CTIS Part I — objectives, methods, condition coding
Conditions and MedDRA coding
Healthy Volunteers
| Version | Level | Code | Term | System organ class |
|---|---|---|---|---|
| 26.0 | LLT | 10088820 | Clinical trial healthy volunteer | 100000004848 |
Sponsors and contacts
Sponsor organisations, regulatory contacts, third parties
UCB Biopharma
- Sponsor organisation
- UCB Biopharma
- Address
- Researchdreef 60
- City
- Anderlecht
- Postcode
- 1070
- Country
- Belgium
Scientific contact point
- Organisation
- UCB Biopharma
- Contact name
- UCB Cares
Public contact point
- Organisation
- UCB Biopharma
- Contact name
- UCB Cares
Locations
1 EU/EEA country · 1 investigational sites
By country
| Country | MS status | Planned subjects | Sites |
|---|---|---|---|
| Netherlands | Ended | 14 | 1 |
| Rest of world | — | 0 | — |
Investigational sites
Pharmaceutical Research Associates Group B.V.
#001_00270428: 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 | 2024-08-05 | 2024-11-26 | 2024-08-05 | 2024-08-23 |
Results and documents
Annex IV summary of results, Annex V layperson summary, and all documents registered in CTIS for this trial
Documents 1 file
Public protocol annexes, IB summaries, regulatory submissions and post-authorisation documents registered in CTIS.
| Type | Title | Version |
|---|---|---|
| Clinical study report (for publication) | dv0012-csr-final-CTIS-public | NA |
Application history
3 submissions — initial application plus substantial / non-substantial modifications
| # | Type | Code | Submitted | Reference MS | Conclusion | Decision date |
|---|---|---|---|---|---|---|
| 1 | INITIAL | IN | 2024-04-10 | Netherlands | Acceptable 2024-06-12
|
2024-06-12 |
| 2 | NON SUBSTANTIAL MODIFICATION | NSM-1 | 2024-10-23 | Netherlands | Acceptable 2024-06-12
|
2024-10-23 |
| 3 | NON SUBSTANTIAL MODIFICATION | NSM-2 | 2024-12-03 | Netherlands | Acceptable 2024-06-12
|
2024-12-03 |