Overview
Sponsor-declared trial summary
Phase
Human pharmacology (Phase I) - Other
Status
Ended
Participants planned
44
Countries
2
Sites
9
Urticaria
Key facts
- Sponsor
- Noucor Health S.A.
- Participant type
- Patients, Healthy volunteers
- Age range
- 18-64 years, 65+ years
- Gender
- Male and Female
- Therapeutic area
- Diseases [C] - Respiratory Tract Diseases [C08]
- Trial duration
- 8 Nov 2022 → 9 Apr 2025
- Decision date (initial)
- 2022-09-08
- 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
Urticaria
| Version | Level | Code | Term | System organ class |
|---|---|---|---|---|
| 20.0 | PT | 10046735 | Urticaria | 100000004858 |
| 21.1 | LLT | 10001723 | Allergic rhinitis | 10038738 |
Sponsors and contacts
Sponsor organisations, regulatory contacts, third parties
Noucor Health S.A.
- Sponsor organisation
- Noucor Health S.A.
- Address
- Avinguda Del Cami Reial 51-57
- City
- Palau-Solita I Plegamans
- Postcode
- 08184
- Country
- Spain
Scientific contact point
- Organisation
- Noucor Health S.A.
- Contact name
- Daniel Peris
Public contact point
- Organisation
- Noucor Health S.A.
- Contact name
- Daniel Peris
Locations
2 EU/EEA countries · 9 investigational sites
By country
| Country | MS status | Planned subjects | Sites |
|---|---|---|---|
| Portugal | Ended | 22 | 4 |
| Spain | Ended | 22 | 5 |
| Rest of world | — | 0 | — |
Investigational sites
CCAB Centro Clinico Academico Braga Associacao
Gastroenterology Department, Lugar De Sete Fontes S Victor, 4710-243, Braga
Blueclinical Investigacao E Desenvolvimento Em Saude Lda.
BlueClinical Phase I, East Wing, Rua De Sarmento De Beires 153 3rd Floor 4 Floor, Porto
Hospital Pedro Hispano
Early Phase Clinical Trials Unit | ULSM+BlueClinical, Rua Doutor Eduardo Torres 1, 4450-113, Matosinhos
Centro Hospitalar De Vila Nova De Gaia Espinho
Early Phase Clinical Trial Unit | CHVNG/E + BlueClinical, Rua Conceicao Fernandes, 4434-502, Vila Nova De Gaia
Hospital Universitario La Paz
Clinical Pharmacology, Paseo Castellana 261, 28046, Madrid
Hospital Universitario De La Princesa
Clinical Pharmacology, Calle De Diego De Leon 62, 28006, Madrid
Hospital Clinico San Carlos
Clinical Pharmacology, Calle Del Profesor Martin Lagos Sn, 28040, Madrid
Municipal Institute Of Medical Investigation
Unidad de Investigación Clínica del IMIM, Calle Del Doctor Aiguader 80, 08003, Barcelona
Hospital De La Santa Creu I Sant Pau
Gastroenterology Department, Calle De San Antonio Maria Claret 167, 08025, Barcelona
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 |
|---|---|---|---|---|---|
| Portugal | 2022-11-08 | 2025-04-03 | 2022-11-17 | 2025-03-14 | |
| Spain | 2022-12-12 | 2025-04-09 | 2023-01-09 | 2025-03-26 |
Application history
10 submissions — initial application plus substantial / non-substantial modifications
| # | Type | Code | Submitted | Reference MS | Conclusion | Decision date |
|---|---|---|---|---|---|---|
| 1 | INITIAL | IN | 2022-06-03 | Spain | Acceptable 2022-07-26
|
2022-08-01 |
| 2 | NON SUBSTANTIAL MODIFICATION | NSM-1 | 2023-03-14 | Spain | Acceptable 2022-07-26
|
2023-03-14 |
| 3 | SUBSTANTIAL MODIFICATION | SM-1 | 2023-03-23 | Spain | Acceptable 2023-06-02
|
2023-06-02 |
| 4 | SUBSTANTIAL MODIFICATION | SM-2 | 2023-06-30 | Acceptable | 2023-08-22 | |
| 5 | NON SUBSTANTIAL MODIFICATION | NSM-2 | 2024-01-16 | Spain | Acceptable | 2024-01-16 |
| 6 | SUBSTANTIAL MODIFICATION | SM-3 | 2024-01-25 | Spain | Acceptable 2024-03-04
|
2024-03-04 |
| 7 | SUBSTANTIAL MODIFICATION | SM-4 | 2024-04-30 | Spain | Acceptable 2024-06-04
|
2024-06-05 |
| 8 | SUBSTANTIAL MODIFICATION | SM-5 | 2024-06-18 | Spain | Acceptable 2024-07-19
|
2024-07-19 |
| 9 | SUBSTANTIAL MODIFICATION | SM-6 | 2024-12-18 | Spain | Acceptable 2025-01-21
|
2025-01-21 |
| 10 | NON SUBSTANTIAL MODIFICATION | NSM-3 | 2025-02-05 | Spain | Acceptable 2025-01-21
|
2025-02-05 |