Overview
Sponsor-declared trial summary
Phase
Human pharmacology (Phase I) - First administration to humans
Status
Ended
Participants planned
18
Countries
2
Sites
7
Ulcerative colitis
Key facts
- Sponsor
- Sorriso Pharmaceuticals Inc.
- Participant type
- Patients
- Age range
- 18-64 years
- Gender
- Male and Female
- Therapeutic area
- Diseases [C] - Digestive System Diseases [C06]
- Trial duration
- 20 Oct 2024 → 22 Oct 2024
- Decision date (initial)
- 2024-06-17
- Transition trial
- No
- Low-intervention
- No
- Rare-disease indication
- No
- Vulnerable population
- Yes
External identifiers
- EU CT number
- 2023-510324-77-00
- ClinicalTrials.gov
- NCT06080048
Trial design
CTIS Part I — objectives, methods, condition coding
Conditions and MedDRA coding
Ulcerative colitis
| Version | Level | Code | Term | System organ class |
|---|---|---|---|---|
| 20.1 | LLT | 10045365 | Ulcerative colitis | 10017947 |
Sponsors and contacts
Sponsor organisations, regulatory contacts, third parties
Sorriso Pharmaceuticals Inc.
- Sponsor organisation
- Sorriso Pharmaceuticals Inc.
- Address
- 9295 South 1300 East Suite 3
- City
- Sandy
- Postcode
- 84094-3127
- Country
- United States
Scientific contact point
- Organisation
- Sorriso Pharmaceuticals Inc.
- Contact name
- Sara Barbat
Public contact point
- Organisation
- Sorriso Pharmaceuticals Inc.
- Contact name
- Sara Barbat
Locations
2 EU/EEA countries · 7 investigational sites
By country
| Country | MS status | Planned subjects | Sites |
|---|---|---|---|
| Bulgaria | Ended | 2 | 1 |
| Poland | Ended | 7 | 6 |
| Rest of world
Georgia, Ukraine, United Kingdom
|
— | 9 | — |
Investigational sites
Multiprofile Hospital for Active Treatment Sveta Sofia
Gastroenterology, Bulevard Bilgariya 104, 1404, Sofiya
Niepubliczny Zaklad Opieki Zdrowotnej VIVAMED Jadwiga Miecz
Poradnia gastroenterologiczna, Ul. Zamiejska 17, 03-580, Warszawa
Planetmed Sp. z o.o.
Gastroenterologia, Ul. Lubinowa 12/8, 52-210, Wroclaw
Vita Longa Sp. z o.o.
Badań Klinicznych, Ul. Uniczowska 6, 40-748, Katowice
Medical Network Sp. z o.o.
WIP Warsaw IBD Point Profesor Kierkuś, Ul. Plowiecka 103, 04-501, Warsaw
Bodyclinic Sp. z o.o. sp.k.
Klinika Gastroenterologii i Chorób Wewnętrznych, Ul. Ulica Jozefa Sierakowskiego 4/u3, 03-712, Warsaw
Endoskopia Sp. z o.o.
Gastroenterologia, Ul. Boleslawa Chrobrego 6/8, 81-756, Sopot
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 |
|---|---|---|---|---|---|
| Bulgaria | 2024-10-20 | 2024-10-20 | |||
| Poland | 2024-10-20 | 2024-10-21 |
Application history
2 submissions — initial application plus substantial / non-substantial modifications
| # | Type | Code | Submitted | Reference MS | Conclusion | Decision date |
|---|---|---|---|---|---|---|
| 1 | INITIAL | IN | 2024-02-21 | Poland | Acceptable with conditions 2024-06-10
|
2024-06-14 |
| 2 | SUBSTANTIAL MODIFICATION | SM-1 | 2024-07-01 | Poland | Acceptable 2024-09-02
|
2024-09-06 |