Overview
Sponsor-declared trial summary
Phase
Human pharmacology (Phase I) - First administration to humans
Status
Ongoing, recruiting
Participants planned
56
Countries
1
Sites
7
Cold Induced Urticaria
Key facts
- Sponsor
- Granular Therapeutics Limited
- Participant type
- Patients, Healthy volunteers
- Age range
- 18-64 years
- Gender
- Male and Female
- Therapeutic area
- Diseases [C] - Skin and Connective Tissue Diseases [C17]
- Trial duration
- 29 Aug 2025 → ongoing
- Decision date (initial)
- 2025-08-27
- 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
Cold Induced Urticaria
| Version | Level | Code | Term | System organ class |
|---|---|---|---|---|
| 21.1 | LLT | 10009870 | Cold-induced urticaria | 10040785 |
Sponsors and contacts
Sponsor organisations, regulatory contacts, third parties
Granular Therapeutics Limited
- Sponsor organisation
- Granular Therapeutics Limited
- Address
- Innovation House, Innovation Way, Discovery Park Innovation Way Discovery Park
- City
- Sandwich
- Postcode
- CT13 9FF
- Country
- United Kingdom
Scientific contact point
- Organisation
- Granular Therapeutics Limited
- Contact name
- Info-Granular
Public contact point
- Organisation
- Granular Therapeutics Limited
- Contact name
- Info-Granular
Locations
1 EU/EEA country · 7 investigational sites
By country
| Country | MS status | Planned subjects | Sites |
|---|---|---|---|
| Germany | Ongoing, recruiting | 56 | 7 |
| Rest of world | — | 0 | — |
Investigational sites
Universitaetsmedizin der Johannes Gutenberg-Universitaet Mainz KöR
Hautklinik und Poliklinik, Langenbeckstrasse 1, Oberstadt, Mainz
Universitatsklinikum Munster AöR
Department of Dermatology, Von-Esmarch-Strasse 58, Sentrup, Muenster
Dermatologische Praxis Dr. med. Abdou Zarzour
Hautarztpraxis Dr. med Abdou Zarour, Grosse Steinstrasse 12, 06108, Halle (Saale)
Universitaetsklinikum Giessen und Marburg GmbH
Klinik für Dermatologie und Allergologie, Baldingerstrasse 1, 35043, Marburg
Charite Research Organisation GmbH
Charite Research Organisation, Chariteplatz 1, Mitte, Berlin
Charite Universitaetsmedizin Berlin KöR
Institut für Allergieforschung IFA, Hindenburgdamm 30, Lichterfelde, Berlin
Universitaetsklinikum Tuebingen AöR
Studienzentrum Immundermatologie, Liebermeisterstrasse 25, Innenstadt, Tuebingen
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 |
|---|---|---|---|---|---|
| Germany | 2025-08-29 | 2025-09-15 |
Application history
6 submissions — initial application plus substantial / non-substantial modifications
| # | Type | Code | Submitted | Reference MS | Conclusion | Decision date |
|---|---|---|---|---|---|---|
| 1 | INITIAL | IN | 2025-06-06 | Germany | Acceptable 2025-08-26
|
2025-08-27 |
| 2 | NON SUBSTANTIAL MODIFICATION | NSM-1 | 2025-10-15 | Germany | Acceptable 2025-08-26
|
2025-10-15 |
| 3 | SUBSTANTIAL MODIFICATION | SM-1 | 2025-11-14 | Germany | Acceptable 2026-01-12
|
2026-01-16 |
| 4 | SUBSTANTIAL MODIFICATION | SM-2 | 2026-01-26 | Germany | Acceptable 2026-02-23
|
2026-02-27 |
| 5 | NON SUBSTANTIAL MODIFICATION | NSM-2 | 2026-03-17 | Germany | Acceptable 2026-02-23
|
2026-03-17 |
| 6 | SUBSTANTIAL MODIFICATION | SM-3 | 2026-04-09 | Germany | Acceptable | 2026-05-29 |