Status:
COMPLETED
A Clinical Trial to Assess the Safety of SOR102 in Healthy Participants and Patients With Ulcerative Colitis
Lead Sponsor:
Sorriso Pharmaceuticals, Inc.
Conditions:
Ulcerative Colitis
Eligibility:
All Genders
18-75 years
Phase:
PHASE1
Brief Summary
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 mult...
Eligibility Criteria
Inclusion
- Key
- 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
- Key
Exclusion
- Any diagnosis of IBD except for UC.
- History of fistula(e), strictures or surgery, known intestinal obstruction, or diagnosis of toxic megacolon.
- 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.
Key Trial Info
Start Date :
October 24 2023
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
November 8 2024
Estimated Enrollment :
22 Patients enrolled
Trial Details
Trial ID
NCT06080048
Start Date
October 24 2023
End Date
November 8 2024
Last Update
November 29 2024
Active Locations (2)
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1
Arensia Exploratory Medicine
Tbilisi, Georgia
2
Arensia Exploratory Medicine
Kyiv, Ukraine