A Clinical Trial to Assess the Safety of SOR102 in Healthy Participants and Patients With Ulcerative Colitis

• Status: Recruiting
• Trial end date: 2025-04-01
• Target enrollment: 0
• Participant gender: All

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 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).

• Phase: Phase 1
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Sorriso Pharmaceuticals, Inc.

Criteria

Key Inclusion Criteria:

• 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 Criteria:

• 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.