NCT06080048CompletedPhase 1
A Clinical Trial to Assess the Safety of SOR102 in Healthy Participants and Patients With Ulcerative Colitis
A Ph I Randomized Double-Blind First-in-Human Single Ascending Dose & Multiple Dose Study to Investigate the Safety Tolerability and Pharmacokinetics of SOR102 in Healthy Adult Participants and Patient Volunteers With Mild to Severe Ulcerative Colitis
Source: ClinicalTrials.gov · Last updated 29 Nov 2024
Brief summary (registry, in English)
SOR102-101 is a Phase 1, 3-part, randomised, double-blind, placebo-controlled, FIH study to determine the safety, tolerability, and PK of single, ascending oral doses (SAD) of SOR102 (Part 1) and multiple oral doses (Part 2) of SOR102 in healthy adult participants, and to assess the safety, tolerability, PK, and biological activity of multiple oral doses of SOR102 in patients with mild to severe UC (Part 3).
- Status (registry)
- Completed
- Phase (registry)
- Phase 1
- Study type
- Interventional
- Enrollment
- 22 (actual)
- First submitted
- 6 Oct 2023
- Start date
- 24 Oct 2023
- Primary completion date
- 16 Oct 2024
- Lead sponsor
- Sorriso Pharmaceuticals, Inc.
- Diseases
- Ulcerative colitis
- NCT number
- NCT06080048
- EU CT number
- 2023-510324-77-00
What you commit to
- Study type: Interventional · Phase 1
- Participants enrolled: 22
- From 24 Oct 2023 to the primary completion date, 16 Oct 2024
- 9 sites in 4 countries
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Concurrent use of any biologic drug.
- Prior primary efficacy failure or secondary loss of response to more than one biologic or new small molecule therapy (i.e., JAK inhibitors or S1P receptor modulators) indicated for the treatment of UC. This does not include prior discontinuation due to drug intolerance.
Other illness
- History of fistula(e), strictures or surgery, known intestinal obstruction, or diagnosis of toxic megacolon.
Other
- Any diagnosis of IBD except for UC.
Who the study is looking for
- Male or females, of any ethnic origin.
- Established diagnosis of UC by standard criteria for \>3 months.
- Disease evaluable by sigmoidoscopy.
- Mildly to severely active UC as determined by central reader in combination with other assessments of disease
Age in the registry: 18 years to 75 years · Sex: All · Accepts healthy volunteers
Sites (9)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Multiprofile Hospital for Active Treatment Sveta Sofia Coordinator of this site? Confirm its status | Sofiya | Bulgaria | Completed |
| Arensia Exploratory Medicine Coordinator of this site? Confirm its status | Tbilisi | Georgia | Unknown status |
| Vita Longa Sp. Z o.o. Coordinator of this site? Confirm its status | Katowice | Poland | Completed |
| Endoskopia Sp z o.o. Coordinator of this site? Confirm its status | Sopot | Poland | Completed |
| Medical Network Sp z o o Coordinator of this site? Confirm its status | Warsaw | Poland | Completed |
| Bodyclinic sp. z o.o. sp.k. Coordinator of this site? Confirm its status | Warsaw | Poland | Completed |
| Niepubliczny Zaklad Opieki Zdrowotnej VIVAMED Jadwiga Miecz Coordinator of this site? Confirm its status | Warszawa | Poland | Completed |
| PlanetMed Sp. z o.o. Coordinator of this site? Confirm its status | Wroclaw | Poland | Completed |
| Arensia Exploratory Medicine Coordinator of this site? Confirm its status | Kyiv | Ukraine | Unknown status |
Related publications
This page is information, not medical advice. Discuss any trial with your doctor.